Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Phase 1
Completed
- Conditions
- HCV Infection
- Interventions
- Registration Number
- NCT00931281
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.
- Detailed Description
This is a multiple ascending dose, non-fasting, open label, randomized study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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 within the 6-month period prior to study drug administration
- donation or loss of 550mL 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
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ABT-450 ABT-450/ritonavir 2 Placebo for ABT-450 Placebo for ABT-450/placebo for ritonavir 2 Placebo for ritonavir Placebo for ABT-450/placebo for ritonavir 1 ritonavir ABT-450/ritonavir
- Primary Outcome Measures
Name Time Method Pharmacokinetics (blood draws, pre- and post-dose) 17 days Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 18161
🇺🇸Waukegan, Illinois, United States
Site Reference ID/Investigator# 18161🇺🇸Waukegan, Illinois, United States