Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

December 17, 2010 updated by: Abbott

An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation

The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Study Type

Interventional

Enrollment (Actual)

40

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# 27781

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Overall healthy subjects
  • Non-childbearing potential females included

Exclusion Criteria

  • Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
  • 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 with the 6-month period prior to study drug administration
  • Abnormal screening laboratory results that are considered clinically significant by the investigator
  • Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
  • Previous exposure to ABT-450

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Low dose ABT-450 capsule and ritonavir capsules (reference).
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Active Comparator: B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Active Comparator: C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Active Comparator: D
High dose ABT-450 capsule and ritonavir capsules (reference).
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Active Comparator: E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
Time Frame: 72 hrs post dose
72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
Time Frame: 72 hrs post dose
72 hrs post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir
Time Frame: Through 30 days post last dose.
Through 30 days post last dose.

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Study Director: Adebayo Lawal, M.D., 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

February 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2010

Last Update Submitted That Met QC Criteria

December 17, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-797

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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