An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
Overview
- Phase
- Phase 1
- Intervention
- ABT-072
- Conditions
- Hepatitis C
- Sponsor
- Abbott
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Tablet 1 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
Intervention: ABT-072
Tablet 2 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
Intervention: ABT-072
Outcomes
Primary Outcomes
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Time Frame: 4 days post each dose
Secondary Outcomes
- 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.)