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

NCT ID: NCT01489345

Last Updated: 2012-08-01

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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ONO-2952 Healthy adult subjects Multiple dose Safety Tolerability Pharmacokinetics

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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Arm 1: Experimental

Group Type EXPERIMENTAL

ONO-2952

Intervention Type DRUG

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

Arm 2: Placebo Comparator

Group Type PLACEBO_COMPARATOR

ONO-2952 Matching Placebo

Intervention Type DRUG

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

Interventions

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ONO-2952

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

Intervention Type DRUG

ONO-2952 Matching Placebo

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

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

Exclusion Criteria

* History or presence of clinically significant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ono Pharma USA, Inc

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Austin Clinical Site

Austin, Texas, United States

Site Status

Countries

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United States

References

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Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4.

Reference Type DERIVED
PMID: 26249232 (View on PubMed)

Other Identifiers

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ONO-2952POU002

Identifier Type: -

Identifier Source: org_study_id