Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: HCV Infection
In brief
The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.
Key facts
- Study ID
- NCT00895102
- Run by
- Abbott
- People needed
- 34
- Starts
- 2009-04-01
- 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 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
Where it is running
- Site Reference ID/Investigator# 19441 — Waukegan, Illinois, United States
Full record on ClinicalTrials.gov
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