Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Phase 1
Completed
- Conditions
- HCV Infection
- Interventions
- Registration Number
- NCT01181427
- Lead Sponsor
- Abbott
- Brief Summary
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Ascending Dose (SAD) ABT-267 Healthy volunteers, receiving single ascending doses of ABT-267 or placebo. Single Ascending Dose (SAD) Placebo Healthy volunteers, receiving single ascending doses of ABT-267 or placebo. Multiple Ascending Dose (MAD) ABT-267 Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. Multiple Ascending Dose (MAD) Placebo Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. Multiple Ascending Dose (MAD) Cytochrome P450 inhibitor Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor. Antiviral Activity Placebo HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days. Resistance Monitoring Blood Sample Collection HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected Food Effect (FE) ABT-267 Healthy volunteers, receiving ABT-267, multi-dose, food effect. Antiviral Activity ABT-267 HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.
- Primary Outcome Measures
Name Time Method Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. Up to 15 days or less Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine). Update to 20 days or less
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Site Reference ID/Investigator# 43322
🇺🇸Waukegan, Illinois, United States
Site Reference ID/Investigator# 42707
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 42708
🇺🇸Orlando, Florida, United States