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

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00423761
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood levels of GW876008 and midazolam collected 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

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Dallas, Texas, United States