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A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults

NCT ID: NCT00752687

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

Detailed Description

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A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers

Group Type OTHER

ABT-072

Intervention Type DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

placebo

Intervention Type DRUG

Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

2

HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD

Group Type OTHER

ABT-072

Intervention Type DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

placebo

Intervention Type DRUG

Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

Interventions

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ABT-072

Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

Intervention Type DRUG

placebo

Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Criteria for Healthy Adults:

* Informed consent has been obtained
* Subject is in general good health
* If female, then postmenopausal
* If female, then not pregnant
* If male, must be surgically sterile or both he and the partner must use birth control
* Body Mass Index is 18 to 29, inclusive

Criteria for HCV-infected Adults:

* Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
* Subject is infected with HCV genotype 1 with detectable HCV RNA of \> 50,000 IU/mL

Exclusion Criteria

Criteria for Healthy Adults:

* If female, then pregnant or breast feeding
* Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
* Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
* Alcohol intake within 48 hours prior to study drug administration

Criteria for HCV-infected Adults:

* Need for prescription or over-the-counter medication
* Child Pugh score \> 5 or clinical evidence of cirrhosis
* No other cause for liver disease other than HCV infection
* ALT or AST \> 4 x ULN
* Creatinine \> ULN
* Clinically significant abnormal ECG
* HCV RNA levels above the level of assay quantification
* TSH values outside normal range
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Locations

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Global Medical Information

Abbott Park, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M10-573

Identifier Type: -

Identifier Source: org_study_id