Status:
COMPLETED
An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00423761
Start Date
December 1 2006
Last Update
May 18 2009
Active Locations (1)
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1
GSK Investigational Site
Dallas, Texas, United States, 75247