Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
Phase 1
Completed
- Conditions
- HCV Infection
- Interventions
- Registration Number
- NCT00850044
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- overall healthy subjects
- non-childbearing potential females included
Exclusion Criteria
- history of significant sensitivity to any drug
- positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
- history of gastrointestinal issues or procedures
- history of seizures, diabetes or cancer (except basal cell carcinoma)
- clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
- use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
- donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
- abnormal screening laboratory results that are considered clinically significant by the investigator
- current enrollment in another clinical study
- previous enrollment in this study
- recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
- pregnant or breastfeeding female
- requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 4 Placebo for ritonavir Placebo for ABT-450/placebo for ritonavir 4 placebo for ABT-450 Placebo for ABT-450/placebo for ritonavir 1 ABT-450 ABT-450 2 placebo for ABT-450 Placebo for ABT-450 3 ABT-450 ABT-450/ritonavir 3 ritonavir ABT-450/ritonavir
- Primary Outcome Measures
Name Time Method Pharmacokinetics (blood draws, pre- and post-dose) 4 days Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) 10 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 15981
🇺🇸Waukegan, Illinois, United States