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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

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ESN364 Drug: Placebo Phase 1

Detailed Description:
This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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 -
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : May 23, 2018

Arm Intervention/treatment
Experimental: ESN364 dose-1 group in Part 1
Healthy male subjects will receive a single dose of ESN364.
Drug: ESN364
ESN364 will be administered orally.

Experimental: ESN364 dose-2 group in Part 1
Healthy male subjects will receive a single dose of ESN364.
Drug: ESN364
ESN364 will be administered orally.

Placebo Comparator: Placebo group in Part 1
Healthy male subjects will receive a single dose of Placebo.
Drug: Placebo
Placebo will be administered orally.

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.
Drug: ESN364
ESN364 will be administered orally.

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.
Drug: ESN364
ESN364 will be administered orally.

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.
Drug: ESN364
ESN364 will be administered orally.

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.
Drug: Placebo
Placebo will be administered orally.

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.
Drug: Placebo
Placebo will be administered orally.

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.
Drug: Placebo
Placebo will be administered orally.




Primary Outcome Measures :
  1. 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).

  2. Safety assessed by incidence of AEs in Part 2 [ Time Frame: Up to Day 24 in Part 2 ]
    AEs will be coded using MedDRA.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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

  30. 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

  31. 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


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. 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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436849


Locations
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Japan
Site JP00001
Fukuoka, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03436849     History of Changes
Other Study ID Numbers: 2693-CL-0020
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc:
ASP2693
Pharmacodynamics
Pharmacokinetics
ESN364
Safety