A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00460707
First received: April 12, 2007
Last updated: May 31, 2012
Last verified: February 2011

April 12, 2007
May 31, 2012
April 2007
Not Provided
  • 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Healthy Subjects
  • Nausea and Vomiting, Chemotherapy-Induced
  • Drug: Casopitant
  • Drug: Ketoconazole
    Other Names:
    • Casopitant
    • Ketoconazole
Not Provided
Johnson BM, Adams LM, Zhang K, Gainer SD, Kirby LC, Blum RA, Apseloff G, Morrison RA, Schutz RA, Lebowitz PF. Ketoconazole and rifampin significantly affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1 receptor antagonist. J Clin Pharmacol. 2010 Aug;50(8):951-9. doi: 10.1177/0091270009353761. Epub 2010 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Not Provided
Not Provided

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
NKV109990
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP