A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00460707
First received: April 12, 2007
Last updated: May 31, 2012
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects Nausea and Vomiting, Chemotherapy-Induced |
Drug: Casopitant Drug: Ketoconazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Ketoconazole
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 72 |
| Study Start Date: | April 2007 |
Intervention Details:
-
Drug: Casopitant
Drug: Ketoconazole
- Casopitant
- Ketoconazole
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460707
Locations
| United States, Kansas | |
| GSK Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14202 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43212 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00460707 History of Changes |
| Other Study ID Numbers: | NKV109990 |
| Study First Received: | April 12, 2007 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
GW679769 healthy adult subjects casopitant ketoconazole |
Additional relevant MeSH terms:
|
Vomiting Signs and Symptoms, Digestive Signs and Symptoms Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013