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Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

NCT ID: NCT00982826

Last Updated: 2010-10-21

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

Detailed Description

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The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ABT-072 tablet single ascending dose

Group Type EXPERIMENTAL

ABT-072

Intervention Type DRUG

See Arms information for a detailed description.

2

Placebo tablet

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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3

ABT-072 tablet administered under non-fasting conditions.

Group Type EXPERIMENTAL

ABT-072

Intervention Type DRUG

See Arms information for a detailed description.

4

ABT-072 tablet administered under fasting conditions

Group Type EXPERIMENTAL

ABT-072

Intervention Type DRUG

See Arms information for a detailed description.

5

ABT-072 tablet multiple ascending dose

Group Type EXPERIMENTAL

ABT-072

Intervention Type DRUG

See Arms information for a detailed description.

Interventions

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ABT-072

See Arms information for a detailed description.

Intervention Type DRUG

Placebo

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Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overall healthy subjects, non-childbearing females included.

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.
* Pregnant or breast-feeding female.
* 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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Daniel Cohen

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 23742

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M11-057

Identifier Type: -

Identifier Source: org_study_id