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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2021-03-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ONO-2910 (Part A and B)

Group Type EXPERIMENTAL

ONO-2910

Intervention Type DRUG

Single ascending dose of ONO-2910 will be administered orally.

Placebo (Part A)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of placebo will be administered orally.

ONO-2910 (Part C and D)

Group Type EXPERIMENTAL

ONO-2910

Intervention Type DRUG

Multiple ascending dose of ONO-2910 will be administered orally.

Placebo (Part C and D)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple dose of placebo will be administered orally.

Interventions

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ONO-2910

Single ascending dose of ONO-2910 will be administered orally.

Intervention Type DRUG

Placebo

Single dose of placebo will be administered orally.

Intervention Type DRUG

ONO-2910

Multiple ascending dose of ONO-2910 will be administered orally.

Intervention Type DRUG

Placebo

Multiple dose of placebo will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes