NCT00423761CompletedPhase 1
An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
Study Overview
Brief Summary
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (1)
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