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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: GW876008

Drug: midazolam

Study type

Interventional

Funder types

Industry

Identifiers

CRH103152

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.