A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Hepatitis C
In brief
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.
Key facts
- Study ID
- NCT00752687
- Run by
- Abbott
- People needed
- 100
- Starts
- 2008-09-01
- Last updated by the study team
- 2010-10-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Global Medical Information — Abbott Park, Illinois, United States
Full record on ClinicalTrials.gov
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