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

A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Doses (7 Days) of ABT-072 and an Open-label Study to Evaluate the Effect of Food on the Pharmacokinetic

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982826

Enrollment

Registered

2009-09-23

Start date

2009-09-30

Completion date

2010-01-31

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, Single and Multiple Ascending Dose, Food Effect

Brief summary

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.

Detailed description

The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Interventions

DRUGABT-072

See Arms information for a detailed description.

DRUGPlacebo

See Arms information for a detailed description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

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 determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.	Up to 14 days post last dose.
To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.	72 hours post last dose.

Secondary

Measure	Time frame
To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.	72 hours post last dose.

Countries

United States

Outcome results

None listed

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