Status:
COMPLETED
ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-44 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03361540
Start Date
November 14 2017
End Date
April 30 2018
Last Update
October 21 2024
Active Locations (1)
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1
Site JP00001
Toshima City, Tokyo, Japan