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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Midazolam

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.