Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ONO-2910; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04504760

ONO-2910-01

Details and patient eligibility

About

To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

Full description

This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.

Enrollment: 80 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Japanese healthy adult male subjects (Part A and C)
2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
3. Caucasian healthy adult male subjects (Part D)
4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

Exclusion criteria

1. Subjects currently with or with a history of disease
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

ONO-2910 (Part A and B)

Experimental group

Treatment:

Drug: ONO-2910

Drug: ONO-2910

Placebo (Part A)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

ONO-2910 (Part C and D)

Experimental group

Treatment:

Drug: ONO-2910

Drug: ONO-2910

Placebo (Part C and D)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo