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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: ABT-072; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Site Reference ID/Investigator# 23742

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; ABT-072 tablet single ascending dose	Drug: ABT-072; See Arms information for a detailed description.
Experimental: 2; Placebo tablet	Drug: Placebo; See Arms information for a detailed description.
Experimental: 3; ABT-072 tablet administered under non-fasting conditions.	Drug: ABT-072; See Arms information for a detailed description.
Experimental: 4; ABT-072 tablet administered under fasting conditions	Drug: ABT-072; See Arms information for a detailed description.
Experimental: 5; ABT-072 tablet multiple ascending dose	Drug: ABT-072; See Arms information for a detailed description.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Daniel Cohen, Abbott

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): October 21, 2010
• Last Update Submitted That Met QC Criteria: October 19, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Phase 1; Food Effect; Single and Multiple Ascending Dose
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: M11-057