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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: August 2, 2017
Last verified: August 2017
  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
Nausea and Vomiting, Chemotherapy-Induced Drug: Casopitant 150 mg Drug: Ketoconazole Drug: Casopitant 150 mg matching placebo Drug: Casopitant 50 mg Drug: Casopitant 50 mg matching placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
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 in Healthy Subjects

Resource links provided by NLM:


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: 85
Actual Study Start Date: April 16, 2007
Study Completion Date: August 27, 2007
Primary Completion Date: August 27, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
All subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2.
Drug: Casopitant 150 mg
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.
Drug: Ketoconazole
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 Name: Casopitant
Drug: Casopitant 50 mg
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.
Placebo Comparator: Cohort 2, Group A
Subjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2.
Drug: Ketoconazole
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 Name: Casopitant
Drug: Casopitant 150 mg matching placebo
Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
Drug: Casopitant 50 mg matching placebo
Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
Experimental: Cohort 2, Group B
In treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2.
Drug: Casopitant 150 mg
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.
Drug: Ketoconazole
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 Name: Casopitant
Drug: Casopitant 50 mg
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: NKV109990
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460707     History of Changes
Other Study ID Numbers: NKV109990
Study First Received: April 12, 2007
Last Updated: August 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
GW679769
healthy adult subjects
casopitant
ketoconazole

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ketoconazole
Casopitant
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 22, 2017