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

Sponsor

Ono Pharma USA Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01489345

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ONO-2952 Drug: ONO-2952 Matching Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Experimental	Drug: ONO-2952 30 mg to 100 mg QD at a multiple dose, and 21 days duration
Placebo Comparator: Arm 2: Placebo Comparator	Drug: ONO-2952 Matching Placebo 30 mg to 100 mg QD at a multiple dose, and 21 days duration

Arm

Intervention/Treatment

Experimental: Arm 1: Experimental

Drug: ONO-2952

30 mg to 100 mg QD at a multiple dose, and 21 days duration

Placebo Comparator: Arm 2: Placebo Comparator

Drug: ONO-2952 Matching Placebo

30 mg to 100 mg QD at a multiple dose, and 21 days duration

Outcome Measures

Primary Outcome Measures

Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events [36 days]

Secondary Outcome Measures

Characterization of PK of ONO-2952 in plasma samples [36 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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