A Phase 1 interventional study of ketoconazole and casopitant 100 mg in Nausea and Vomiting, Chemotherapy-Induced, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 15 is below the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days.
Drug: casopitant 100 mg
Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole.
Drug: ketoconazole · Drug: casopitant 100 mg
Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days.
Drug: Casopitant 50 mg
Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole.
Drug: ketoconazole · Drug: Casopitant 50 mg
Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time
Also known as: casopitant, ketoconazole
Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.
Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3.
Time frame: Period 1: Day 1, 2 & 3
Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8.
Time frame: Period 2: Day 4, 5, 6, 7, & 8.
clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests
Time frame: throughout the study
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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