A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

October 29, 2010 updated by: Abbott

A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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# 11441

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:

  • Adult Male or Female 18-55 yrs.
  • Subject has provided written consent.
  • Subject is in general good health.
  • If female, subject is postmenopausal.
  • If female, subject is not pregnant and is not breast-feeding.
  • Subject must use birth control methods or be surgically sterile.

Exclusion Criteria:

  • Subject is HAV-IgM, HBsAg or HIV Ab positive.
  • Positive screen for drugs of abuse, alcohol, or smoking.
  • Cannot be on any medication, including over the counter drugs.
  • Cannot have previous history of alcohol or drug abuse.
  • Cannot have history of any major diseases or disorders.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, B
Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Drug: lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
Other Names:
  • Kaletra
  • ABT-378
Drug: rifabutin
rifabutin capsule; see arms for intervention description
Experimental: C
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Drug: lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
Other Names:
  • Kaletra
  • ABT-378
Drug: rifabutin
rifabutin capsule; see arms for intervention description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Time Frame: Approximately 0.5 - 1 month
Approximately 0.5 - 1 month
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time Frame: Approximately 0.5 - 1 month
Approximately 0.5 - 1 month

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Study Director: Angela Nilius, MD, 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

August 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-457

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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