Hepatitis C
Conditions
Keywords
Phase 1
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.
Interventions
DRUGABT-072
Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
DRUGplacebo
Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed