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Status:

COMPLETED

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

Lead Sponsor:

Abbott

Conditions:

Hepatitis C

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

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

Detailed Description

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.

Eligibility Criteria

Inclusion

  • 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 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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00752687

Start Date

September 1 2008

Last Update

October 21 2010

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Global Medical Information

Abbott Park, Illinois, United States, 60064