Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: ABT-072

• Registration Number: NCT00947440
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

Detailed Description

A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2009-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Overall healthy subjects, non-childbearing females included.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet 2 vs. Capsule	ABT-072	Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
Tablet 1 vs. Capsule	ABT-072	Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.

Primary Outcome Measures

Name	Time	Method
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.	4 days post each dose

Secondary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.	Through 14 days post last dose.

Trial Locations

Locations (1)

Site Reference ID/Investigator# 22384; 🇺🇸 Waukegan, Illinois, United States