Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult 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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

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Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo dosed in the same manner as ONO-2952

E

Group Type EXPERIMENTAL

ONO-2952

Intervention Type DRUG

3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study

Interventions

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ONO-2952

3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study

Intervention Type DRUG

Placebo

Placebo dosed in the same manner as ONO-2952

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception