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

NCT ID: NCT03361540

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Single dose of ASP8302 dose-1

Subjects will receive a single dose of ASP8302.

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Single dose of ASP8302 dose-2

Subjects will receive a single dose of ASP8302.

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Single dose of ASP8302 dose-3

Subjects will receive a single dose of ASP8302.

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Single dose of ASP8302 dose-4

Subjects will receive a single dose of ASP8302.

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Single dose of Placebo

Subjects will receive a single dose of Placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Multiple dose of ASP8302 dose-5

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

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Multiple dose of ASP8302 dose-6

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

Group Type: EXPERIMENTAL

ASP8302

Intervention Type: DRUG

ASP8302 will be administered orally.

Multiple dose of Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Interventions

ASP8302

ASP8302 will be administered orally.

Intervention Type: DRUG

Placebo

Placebo will be administered orally.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00001

Toshima City, Tokyo, Japan

Countries

Japan

Other Identifiers

8302-CL-0101

Identifier Type: -

Identifier Source: org_study_id