A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
- Registration Number
- NCT00752687
- Lead Sponsor
- Abbott
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers 2 placebo HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD 1 ABT-072 Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers 2 ABT-072 HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD
- Primary Outcome Measures
Name Time Method Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. 2 weeks Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Global Medical Information
🇺🇸Abbott Park, Illinois, United States