An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.

May 15, 2009 updated by: GlaxoSmithKline

An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects

This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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
    • Texas
      • Dallas, Texas, United States, 75247
        • GSK Investigational Site

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:

  • Healthy males or females.
  • Normal ECG.
  • Agree to remain in the clinic for the time defined in the protocol.
  • Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion Criteria:

  • Any serious medical disorder or condition.
  • Any history of an endocrine disorder.
  • Any clinically significant laboratory abnormality.
  • History of psychiatric illness.
  • Any history of suicidal attempts or behavior.
  • Active peptic ulcer disease.
  • Positive faecal occult blood.
  • The subject smokes or has smoked or has used any nicotine-containing products in the last six months.
  • Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
Time Frame: on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
on Day 1 of Session 1 and on Days 1 and 14 of Session 2.

Secondary Outcome Measures

Outcome Measure
Time Frame
12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2
Time Frame: day 1 session 1; days 1 & 14 session 2
day 1 session 1; days 1 & 14 session 2
vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2
Time Frame: day 1 session 1; days 1, 7 & 14 session 2
day 1 session 1; days 1, 7 & 14 session 2

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, MBChB, MFPM, GlaxoSmithKline

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

December 1, 2006

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRH103152

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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