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A Study of Single Dose of ABT-333 in Healthy Male Adults

NCT ID: NCT00919490

Last Updated: 2010-10-25

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.

Detailed Description

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Conditions

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HCV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Single dose of 400 mg

Group Type EXPERIMENTAL

ABT-333

Intervention Type DRUG

Tablet, see arms for interventional description

Group 2

Single dose of 800 mg after safety evolution of Group I

Group Type EXPERIMENTAL

ABT-333

Intervention Type DRUG

Tablet, see arms for interventional description

Group 3

Single dose of 1200 mg after safety evolution of Group 2

Group Type EXPERIMENTAL

ABT-333

Intervention Type DRUG

Tablet, see arms for interventional description

Group 4

Single dose of 1600 mg after safety evolution of Group 3

Group Type EXPERIMENTAL

ABT-333

Intervention Type DRUG

Tablet, see arms for interventional description

Group 5

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, see arms for interventional description.

Interventions

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ABT-333

Tablet, see arms for interventional description

Intervention Type DRUG

Placebo

Tablet, see arms for interventional description.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has provided written consent.
* Subject is in general good health.

Exclusion Criteria

* See above for main selection criteria.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Japan Co.,Ltd

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Japan Co., Ltd.

Principal Investigators

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Yutaka Yamamura

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 19102

Kagoshima, , Japan

Site Status

Countries

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Japan

Other Identifiers

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M11-023

Identifier Type: -

Identifier Source: org_study_id