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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ASP8302; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03361540

8302-CL-0101

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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56 participants in 8 patient groups, including a placebo group

Single dose of ASP8302 dose-1

Experimental group

Description:

Subjects will receive a single dose of ASP8302.

Treatment:

Drug: ASP8302

Single dose of ASP8302 dose-2

Experimental group

Description:

Subjects will receive a single dose of ASP8302.

Treatment:

Drug: ASP8302

Single dose of ASP8302 dose-3

Experimental group

Description:

Subjects will receive a single dose of ASP8302.

Treatment:

Drug: ASP8302

Single dose of ASP8302 dose-4

Experimental group

Description:

Subjects will receive a single dose of ASP8302.

Treatment:

Drug: ASP8302

Single dose of Placebo

Placebo Comparator group

Description:

Subjects will receive a single dose of Placebo.

Treatment:

Drug: Placebo

Multiple dose of ASP8302 dose-5

Experimental group

Description:

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

Treatment:

Drug: ASP8302

Multiple dose of ASP8302 dose-6

Experimental group

Description:

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

Treatment:

Drug: ASP8302

Multiple dose of Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo