Casopitant 150 mg
DrugCasopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
NCT Number: NCT00460707
Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Overland Park, Kansas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.
Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).
Other names: Casopitant
Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.
Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
Time frame: Day 4 to 9 in Cohort 1.
Time frame: Day 2 to 4 of Period 1
Time frame: Day 4 to 9 of Period 2
Time frame: at Screen, Day -1 & Followup (FU)
Time frame: at Screen, Day -1, 4-7 and FU
Time frame: at Screen & FU
Time frame: Day 1
GlaxoSmithKline
Industry
A Phase I, Randomized, Double-Blind Study to Assess the Effects of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of Repeat Oral Dosing of Casopitant in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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