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

October 19, 2010 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Waukegan, Illinois, United States, 60085
        • Site Reference ID/Investigator# 22384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: ABT-072
See arm description for more information
ACTIVE_COMPARATOR: 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.
Drug: ABT-072
See arm description for more information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 days post each dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Time Frame: Through 14 days post last dose.
Through 14 days post last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (ESTIMATE)

July 28, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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