Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

Key facts

Study ID

NCT00982826

Run by

Abbott

People needed

52

Starts

2009-09-01

Expected to finish

2010-01-01

Last updated by the study team

2010-10-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Overall healthy subjects, non-childbearing females included.

You may not qualify if…

• Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
• Pregnant or breast-feeding female.
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
• Positive screen for drugs of abuse, alcohol, or cotinine.
• 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 preceding study drug administration.

Where it is running

• Site Reference ID/Investigator# 23742 — Waukegan, Illinois, United States

Full record on ClinicalTrials.gov

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