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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00423761
First received: January 17, 2007
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: midazolam
Drug: GW876008
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 25
Study Start Date: December 2006
Intervention Details:
    Drug: midazolam Drug: GW876008
    Other Names:
    • midazolam
    • GW876008
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423761

Locations
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MBChB, MFPM GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00423761     History of Changes
Other Study ID Numbers: CRH103152
Study First Received: January 17, 2007
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pharmacokinetics,
tolerability,
healthy,
subjects

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014