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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects

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ClinicalTrials.gov Identifier: NCT03436849
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE February 22, 2018
Actual Primary Completion Date May 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Safety assessed by incidence of adverse events (AEs) in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
  • Safety assessed by incidence of AEs in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    AEs will be coded using MedDRA.
  • Safety assessed by vital signs: Body temperature in Part 1 [ Time Frame: Up to day 12 in Part 1 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by vital signs: Body temperature in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by vital signs: Blood pressure in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by vital signs: Blood pressure in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by vital signs: Pulse rate in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by vital signs: Pulse rate in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess vital signs as a criterion of safety variables.
  • Safety assessed by laboratory test: Hematology in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by laboratory test: Hematology in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by laboratory test: Biochemistry in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by laboratory test: Biochemistry in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by laboratory test: Urinalysis in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by laboratory test: Urinalysis in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
  • Safety assessed by standard 12-lead electrocardiogram (ECG) in Part 1 [ Time Frame: Up to Day 12 in Part 1 ]
    Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
  • Safety assessed by standard ECG in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
  • Safety assessed by ECG parameters: Heart rate in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: Heart rate in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in multiple dose (MD) of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QT interval in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QT interval in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in MD of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: RR interval in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: RR interval in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in MD of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: PR interval in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: PR interval in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in MD of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QRS interval in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QRS interval in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in MD of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QTc interval corrected by Fridericia method (QTcF) in Part 1 [ Time Frame: Up to 24 hr after dosing in Part 1 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by ECG parameters: QTcF in Part 2 [ Time Frame: Up to 24 hr after dosing on Day 10 in MD of Part 2 ]
    To assess ECG parameters as a criterion of safety variables.
  • Safety assessed by body weight in Part 1 [ Time Frame: Up to Day 3 in Part 1 ]
    To assess body weight as a criterion of safety variables
  • Safety assessed by body weight in Part 2 [ Time Frame: Up to Day 15 in Part 2 ]
    To assess body weight as a criterion of safety variables
  • Safety assessed by menstrual cycle in pre-menopausal females [ Time Frame: Up to an average of two weeks after last dosing ]
    To assess menstrual cycle as a criterion of safety variables
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03436849 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2 ]
    To assess the PK of ESN364 and its metabolite4 in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Percentage of AUCinf (AUCinf(%extrap)) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 ]
    To assess the PK of ESN364 and its metabolite in Part 1.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the last measurable concentration (AUClast) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 ]
    To assess the PK of ESN364 and its metabolite in Part 1.
  • PK parameter for ESN364 and its metabolite: Maximum concentration (Cmax) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Apparent total clearance after extra-vascular dosing (CL/F) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Time of the maximum concentration: (tmax) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Terminal elimination half-life (t1/2) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 metabolite: Metabolite to parent ratio (MPR) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the start of the next dosing interval (AUCtau) in plasma [ Time Frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Peak-trough ratio (PTR) in plasma [ Time Frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Accumulation ratio calculated using AUC (Rac(AUC)) in plasma [ Time Frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Concentration immediately prior to dosing at multiple dosing (Ctrough) in plasma [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • Pharmacodynamic (PD) endpoint for ESN364: Luteinizing hormone (LH) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for LH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for LH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) for LH level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for LH level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Follicle stimulating hormone (FSH) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for FSH level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for FSH level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Sex hormone binding globulin (SHBG) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for SHBG level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for SHBG level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Total testosterone (TT) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for TT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for TT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for TT level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for TT level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Free testosterone (FT) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for FT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for FT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for FT level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for FT level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Estradiol (E) level in plasma [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC12 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC24 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC48 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cmin for E level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: tmin for E level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUCtau for E level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cpredose for E level [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Progesterone (P) level in plasma [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC12 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC24 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC48 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cmin for P level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: tmin for P level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUCtau for P level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cpredose for P level [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 ]
    To assess the PK of ESN364 and its metabolite4 in Part 1.
  • PK parameter for ESN364 and its metabolite: Percentage of AUCinf (AUCinf(%extrap)) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 ]
    To assess the PK of ESN364 and its metabolite in Part 1.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the last measurable concentration (AUClast) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 ]
    To assess the PK of ESN364 and its metabolite in Part 1.
  • PK parameter for ESN364 and its metabolite: Maximum concentration (Cmax) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Apparent total clearance after extra-vascular dosing (CL/F) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Time of the maximum concentration: (tmax) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: Terminal elimination half-life (t1/2) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 metabolite: Metabolite to parent ratio (MPR) in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 metabolite in Part 1 and Part 2.
  • PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the start of the next dosing interval (AUCtau) in plasma [ Time Frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Peak-trough ratio (PTR) in plasma [ Time Frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Accumulation ratio calculated using AUC (Rac(AUC)) in plasma [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • PK parameter for ESN364 and its metabolite: Concentration immediately prior to dosing at multiple dosing (Ctrough) in plasma [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PK of ESN364 and its metabolite in Part 2.
  • Pharmacodynamic (PD) endpoint for ESN364: Luteinizing hormone (LH) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUClast for LH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for LH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for LH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) for LH level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for LH level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Follicle stimulating hormone (FSH) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUClast for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for FSH level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for FSH level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for FSH level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Sex hormone binding globulin (SHBG) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUClast for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for SHBG level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for SHBG level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for SHBG level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Total testosterone (TT) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUClast for TT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for TT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for TT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for TT level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for TT level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Free testosterone (FT) level in plasma [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC12 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC24 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUC48 for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUClast for FT level [ Time Frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2. ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Cmin for FT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: tmin for FT level [ Time Frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: AUCtau for FT level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 2.
  • PD endpoint for ESN364: Cpredose for FT level [ Time Frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in Part 1 and Part 2.
  • PD endpoint for ESN364: Estradiol (E) level in plasma [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC12 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC24 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC48 for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUClast for E level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cmin for E level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: tmin for E level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUCtau for E level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cpredose for E level [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Progesterone (P) level in plasma [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC12 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC24 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUC48 for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUClast for P level [ Time Frame: Up to 48 hr after first dosing in Part 2. ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cmin for P level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: tmin for P level [ Time Frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: AUCtau for P level [ Time Frame: Before dosing on Day 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
  • PD endpoint for ESN364: Cpredose for P level [ Time Frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2 ]
    To assess the PD of ESN364 in female subjects in Part 2.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
Official Title  ICMJE Phase 1 Study of ESN364 - Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Japanese Male and Healthy Japanese Pre- and Postmenopausal Female Subjects -
Brief Summary The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.
Detailed Description This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: ESN364
    ESN364 will be administered orally.
  • Drug: Placebo
    Placebo will be administered orally.
Study Arms  ICMJE
  • Experimental: ESN364 dose-1 group in Part 1
    Healthy male subjects will receive a single dose of ESN364.
    Intervention: Drug: ESN364
  • Experimental: ESN364 dose-2 group in Part 1
    Healthy male subjects will receive a single dose of ESN364.
    Intervention: Drug: ESN364
  • Placebo Comparator: Placebo group in Part 1
    Healthy male subjects will receive a single dose of Placebo.
    Intervention: Drug: Placebo
  • Experimental: Male ESN364 group in Part 2
    Healthy male subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level.
    Intervention: Drug: ESN364
  • Experimental: Pre-menopausal female ESN364 group in Part 2
    Healthy pre-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level.
    Intervention: Drug: ESN364
  • Experimental: Post-menopausal female ESN364 group in Part 2
    Healthy post-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level.
    Intervention: Drug: ESN364
  • Placebo Comparator: Male placebo group in Part 2
    Healthy male subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.
    Intervention: Drug: Placebo
  • Placebo Comparator: Pre-menopausal female placebo group in Part 2
    Healthy pre-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.
    Intervention: Drug: Placebo
  • Placebo Comparator: Post-menopausal female placebo group in Part 2
    Healthy post-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 23, 2018
Actual Primary Completion Date May 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subject between 20 to < 45 years of age, or female subject between 20 to < 65 years of age.
  • Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
  • Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].

Exclusion Criteria:

  • Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
  • Subject has had previous exposure with ESN364.
  • Subject has any clinically significant history of allergic conditions prior to study drug administration.
  • Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
  • Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
  • Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
  • Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
  • Subjects who are positive for any of urinary drug abuse test or serology test at screening.
  • Subject took a drug or underwent therapy within 2 weeks prior to hospital admission.
  • Subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission.
  • Subjects who had bilateral orchiectomy.
  • Subject has used any inducer of metabolism in the 3 months prior to hospital admission.
  • Subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test.
  • Subject consumes, on average, more than approximately 500 mg/day of caffeine
  • Subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening.
  • Subjects who conducted or is scheduled to conduct any blood donation or blood drawing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03436849
Other Study ID Numbers  ICMJE 2693-CL-0020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP