| April 12, 2007 |
| October 9, 2008 |
| April 2007 |
| |
- Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1. [ Time Frame: Day 4 to 9 in Cohort 1. ]
- Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and [ Time Frame: Day 2 to 4 of Period 1 ]
- casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2. [ Time Frame: Day 4 to 9 of Period 2 ]
|
| - Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1.
- Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and casopitant and ketoconzaole will be checked on Day 4 to 9 of Period 2. |
| Complete list of historical versions of study NCT00460707 on ClinicalTrials.gov Archive Site |
- Safety is evaluated in Cohort 1 by:
- Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU) [ Time Frame: at Screen, Day -1 & Followup (FU) ]
- - Vitals Signs monitored at Screen, Day -1, 4-7 and FU [ Time Frame: at Screen, Day -1, 4-7 and FU ]
- - 12 lead ECGs at Screen & FU [ Time Frame: at Screen & FU ]
- - Adverse Events Monitoring starting at Day 1 [ Time Frame: Day 1 ]
|
| Safety is evaluated in Cohort 1 by:
- Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU)
- Vitals Signs monitored at Screen, Day -1, 4-7 and FU
- 12 lead ECGs at Screen & FU
- Adverse Events Monitoring starting at Day 1 |
| |
| A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults |
| 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 [GW679769] in Healthy Subjects |
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. |
| |
| Phase I |
| Interventional |
| Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics Study |
| Healthy Subjects |
- Drug: Casopitant
- Drug: Ketoconazole
|
| |
| |
| |
| Completed |
| 72 |
|
|
Inclusion criteria:
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ system functions.
- Able to swallow and retain oral medication.
- Subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Exclusion Criteria:
- Current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the study doctor, contraindicates participation.
- Use of an investigational drug within 28 days or 5 half-lives.
- Use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication.
- Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
- Iron deficiency.
- Positive stool for occult blood.
- Female subject who is pregnant or lactating.
- Male subject who has a history of hypogonadism.
- Positive urine drug screen.
- Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen.
- Use of tobacco-containing products within the past 12 months prior to screening.
- History of drug or alcohol abuse or dependence within 6 months of screening.
- History or presence of uncontrolled emesis.
- Presence of active infection.
- History of cholecystectomy or biliary tract disease.
- Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
- Any degree of heart failure.
- Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pommelos or vegetables from the mustard green family within 7 days prior to the first dose unless prior approval is received.
|
| Both |
| 18 Years to 55 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00460707 |
| Study Director, GSK |
| NKV109990 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2008 |