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

NCT03361540 | Completed Phase 1

• 1 other identifier: 8302-CL-0101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Safety; ASP8302

Outcome Measures

Primary Outcomes (7)

• Safety assessed by incidence of adverse events (AEs)

  Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

  Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part

• Safety assessed by vital signs: Body temperature

  To assess vital signs as a criteria of safety variables.

  Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part

• Safety assessed by vital signs: Blood pressure

  To assess vital signs as a criteria of safety variables.

  Up to Day 6 in SAD part Up to Day 19 in MAD part

• Safety assessed by vital signs: Pulse rate

  To assess vital signs as a criteria of safety variables.

  Up to Day 6 in SAD part Up to Day 19 in MAD part

• Number of participants with laboratory value abnormalities and/or AEs

  Number of participants with potentially clinically significant laboratory values.

  Up to Day 6 in SAD part Up to Day 19 in MAD part

• Safety assessed by cardiac troponin

  To assess the cardiovascular system function as a criteria of safety variables.

  Up to Day 6 in SAD part Up to Day 19 in MAD part

• Safety assessed by standard 12-lead electrocardiogram

  To assess the cardiovascular system function as a criteria of safety variables.

  Up to Day 6 in SAD part Up to Day 19 in MAD part

Secondary Outcomes (21)

• Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma

  Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part

• PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma

  Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part

• PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma

  Up to 72 hr after dosing in SAD part Day 1 in MAD part

• PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma

  Up to 72 hr after dosing in SAD part

• PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma

  Day 14 in MAD part

Study Arms (8)

Single dose of ASP8302 dose-1

EXPERIMENTAL

Subjects will receive a single dose of ASP8302.

Drug: ASP8302

Single dose of ASP8302 dose-2

EXPERIMENTAL

Subjects will receive a single dose of ASP8302.

Drug: ASP8302

Single dose of ASP8302 dose-3

EXPERIMENTAL

Subjects will receive a single dose of ASP8302.

Drug: ASP8302

Single dose of ASP8302 dose-4

EXPERIMENTAL

Subjects will receive a single dose of ASP8302.

Drug: ASP8302

Single dose of Placebo

PLACEBO COMPARATOR

Subjects will receive a single dose of Placebo.

Drug: Placebo

Multiple dose of ASP8302 dose-5

EXPERIMENTAL

Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level.

Drug: ASP8302

Multiple dose of ASP8302 dose-6

EXPERIMENTAL

Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level.

Drug: ASP8302

Multiple dose of Placebo

PLACEBO COMPARATOR

Subjects will receive once daily dosing of Placebo for 14 consecutive days.

Drug: Placebo

Interventions

ASP8302 DRUG

ASP8302 will be administered orally.

Multiple dose of ASP8302 dose-5; Multiple dose of ASP8302 dose-6; Single dose of ASP8302 dose-1; Single dose of ASP8302 dose-2; Single dose of ASP8302 dose-3; Single dose of ASP8302 dose-4

Placebo DRUG

Placebo will be administered orally.

Multiple dose of Placebo; Single dose of Placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[BMI = Body weight (kg) ÷ {Body height (m)2}\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Toshima City, Tokyo, Japan

Location

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 5, 2017
• Study Start: November 14, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 21, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)