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

An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947440

Enrollment

Registered

2009-07-28

Start date

2009-07-31

Completion date

Unknown

Last updated

2010-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Phase 1, Bioavailability

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.

Interventions

DRUGABT-072

See arm description for more information

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026