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ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT03361540
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ASP8302 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: ASP8302 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: Single dose of ASP8302 dose-1
Subjects will receive a single dose of ASP8302.
Drug: ASP8302
ASP8302 will be administered orally.
Experimental: Single dose of ASP8302 dose-2
Subjects will receive a single dose of ASP8302.
Drug: ASP8302
ASP8302 will be administered orally.
Experimental: Single dose of ASP8302 dose-3
Subjects will receive a single dose of ASP8302.
Drug: ASP8302
ASP8302 will be administered orally.
Experimental: Single dose of ASP8302 dose-4
Subjects will receive a single dose of ASP8302.
Drug: ASP8302
ASP8302 will be administered orally.
Placebo Comparator: Single dose of Placebo
Subjects will receive a single dose of Placebo.
Drug: Placebo
Placebo will be administered orally.
Experimental: Multiple dose of ASP8302 dose-5
Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level.
Drug: ASP8302
ASP8302 will be administered orally.
Experimental: Multiple dose of ASP8302 dose-6
Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level.
Drug: ASP8302
ASP8302 will be administered orally.
Placebo Comparator: Multiple dose of Placebo
Subjects will receive once daily dosing of Placebo for 14 consecutive days.
Drug: Placebo
Placebo will be administered orally.



Primary Outcome Measures :
  1. Safety assessed by incidence of adverse events (AEs) [ Time Frame: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part ]
    Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

  2. Safety assessed by vital signs: Body temperature [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part ]
    To assess vital signs as a criteria of safety variables.

  3. Safety assessed by vital signs: Blood pressure [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in MAD part ]
    To assess vital signs as a criteria of safety variables.

  4. Safety assessed by vital signs: Pulse rate [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in MAD part ]
    To assess vital signs as a criteria of safety variables.

  5. Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in MAD part ]
    Number of participants with potentially clinically significant laboratory values.

  6. Safety assessed by cardiac troponin [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in MAD part ]
    To assess the cardiovascular system function as a criteria of safety variables.

  7. Safety assessed by standard 12-lead electrocardiogram [ Time Frame: Up to Day 6 in SAD part Up to Day 19 in MAD part ]
    To assess the cardiovascular system function as a criteria of safety variables.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  2. PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  3. PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part Day 1 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  4. PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  5. PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  6. PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  7. PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  8. PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  9. PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  10. PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  11. PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  12. PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  13. PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma [ Time Frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  14. PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma [ Time Frame: Up to Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  15. PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  16. PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine [ Time Frame: Up to 72 hr after dosing in SAD part ]
    To assess the PK of ASP8302 in SAD part.

  17. PK parameter for ASP8302: Renal clearance (CLR) in urine [ Time Frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part ]
    To assess the PK of ASP8302 in SAD part and MAD part.

  18. PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  19. PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine [ Time Frame: Day 14 in MAD part ]
    To assess the PK of ASP8302 in MAD part.

  20. Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter [ Time Frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part ]
    To assess the PD of ASP8302 in SAD part and MAD part.

  21. PD parameter for ASP8302: Salivary secretion [ Time Frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part ]
    To assess the PD of ASP8302 in SAD part and MAD part.



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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: ≥ 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 120 days before screening test or during the screening test to the hospital admission (Day −2).
  • Subjects who conducted or is scheduled to conduct any of the blood donation or blood drawing in designated period before Day −2
  • Subject who received or is scheduled to receive any medications within seven days before the hospital admission.
  • Any deviation from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or on the day of hospital admission (Day −1).
  • Subject who meets any of the criteria for laboratory tests at screening or on the day of hospital admission (Day −2).
  • Any deviation from the normal range of routine 12-lead electrocardiogram at screening.
  • Subjects with a complication or history of drug allergies.
  • Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission.
  • Subjects with a complication or history of hepatic disease.
  • Subjects with a complication or history of cardiac disease.
  • Subjects with a complication or history of respiratory disease except for history of asthma in childhood.
  • Subjects with a complication or history of gastrointestinal disease except for a history of appendicitis.
  • Subjects with a history of gastrointestinal resection except for appendicitis.
  • Subjects with a complication or history of renal disease except for a history of calculus.
  • Subjects with a complication or history of endocrine disease.
  • Subjects with a complication or history of cerebrovascular disease.
  • Subjects with a complication or history of malignant tumor.
  • Subjects who received ASP8302 previously.
  • Subjects who have a habit of excessive smoking or drinking alcohol.

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): NCT03361540


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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03361540     History of Changes
Other Study ID Numbers: 8302-CL-0101
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
Safety
ASP8302