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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT00423761

Run by

GlaxoSmithKline

People needed

25

Starts

2006-12-01

Last updated by the study team

2009-05-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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