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Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers

NCT ID: NCT00895102

Last Updated: 2010-10-13

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.

Detailed Description

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Conditions

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HCV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. ABT-333 Capsule vs ABT-333 Tablet

400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose

Group Type ACTIVE_COMPARATOR

ABT-333 Tablet

Intervention Type DRUG

See Arm Description for more information.

ABT-333 Capsule

Intervention Type DRUG

See arm description for more information

2. ABT-333 Tablet

ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)

Group Type ACTIVE_COMPARATOR

ABT-333 Tablet

Intervention Type DRUG

See Arm Description for more information.

Placebo

Intervention Type DRUG

See Arm Description for more information.

3. Placebo

Placebo tablets, QD, single ascending doses

Group Type PLACEBO_COMPARATOR

ABT-333 Tablet

Intervention Type DRUG

See Arm Description for more information.

Placebo

Intervention Type DRUG

See Arm Description for more information.

Interventions

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ABT-333 Tablet

See Arm Description for more information.

Intervention Type DRUG

Placebo

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Intervention Type DRUG

ABT-333 Capsule

See arm description for more information

Intervention Type DRUG

Other Intervention Names

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ABT-333

Eligibility Criteria

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Inclusion Criteria

* overall healthy subjects;
* non-childbearing potential females included

Exclusion Criteria

* history of significant sensitivity to any drug;
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
* history of gastrointestinal issues or procedures;
* history of seizures, diabetes or cancer (except basal cell carcinoma);
* 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 with the 6-month period prior to study drug administration;
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
* abnormal screening laboratory results that are considered clinically significant by the investigator;
* current enrollment in another clinical study;
* previous enrollment in this study;
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
* pregnant or breastfeeding female;
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
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, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 19441

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M11-032

Identifier Type: -

Identifier Source: org_study_id