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A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults

NCT ID: NCT01081483

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABT-072 Tablet

ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3

Group Type ACTIVE_COMPARATOR

ABT-072

Intervention Type DRUG

See arm description for more information

Placebo

Placebo Tablet, QD, single doses, groups 1-3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

See arm description for more information

Interventions

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ABT-072

See arm description for more information

Intervention Type DRUG

Placebo

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Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overall healthy adult Japanese males

Exclusion Criteria

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
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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Kazuko Kobayashi

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Kagoshima, Prefecture, Japan

Site Status

Countries

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Japan

Other Identifiers

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M11-310

Identifier Type: -

Identifier Source: org_study_id