Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Completed · Phase 1 · Has a placebo group
Conditions studied: HCV Infection
In brief
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.
Key facts
- Study ID
- NCT00931281
- Run by
- Abbott
- People needed
- 38
- Starts
- 2009-06-01
- Last updated by the study team
- 2010-10-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- overall healthy subjects
- non-childbearing potential females included
You may not qualify if…
- 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
Where it is running
- Site Reference ID/Investigator# 18161 — Waukegan, Illinois, United States
Full record on ClinicalTrials.gov
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