An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers

Abbott1 site in 1 country34 target enrollmentApril 2009

ConditionsHCV Infection

InterventionsABT-333 Tablet ABT-333 Capsule Placebo

DrugsABT-333 Tablet Placebo ABT-333 Capsule

Overview

Phase: Phase 1
Intervention: ABT-333 Tablet
Conditions: HCV Infection
Sponsor: Abbott
Enrollment: 34
Locations: 1
Primary Endpoint: To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

June 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

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;