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

Phase 1

Completed

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

• Registration Number: NCT00982826
• Lead Sponsor: Abbott

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo tablet
5	ABT-072	ABT-072 tablet multiple ascending dose
1	ABT-072	ABT-072 tablet single ascending dose
3	ABT-072	ABT-072 tablet administered under non-fasting conditions.
4	ABT-072	ABT-072 tablet administered under fasting conditions

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 23742; 🇺🇸 Waukegan, Illinois, United States