search
Back to results

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

Primary Purpose

Nausea and Vomiting, Chemotherapy-Induced

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Casopitant 150 mg
Ketoconazole
Casopitant 150 mg matching placebo
Casopitant 50 mg
Casopitant 50 mg matching placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring GW679769, healthy adult subjects, casopitant, ketoconazole

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Cohort 1

Cohort 2, Group A

Cohort 2, Group B

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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 ketoconazole will be checked on 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)
- Vitals Signs monitored at Screen, Day -1, 4-7 and FU
- 12 lead ECGs at Screen & FU
- Adverse Events Monitoring starting at Day 1

Full Information

First Posted
April 12, 2007
Last Updated
August 2, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00460707
Brief Title
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 16, 2007 (Actual)
Primary Completion Date
August 27, 2007 (Actual)
Study Completion Date
August 27, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Chemotherapy-Induced
Keywords
GW679769, healthy adult subjects, casopitant, ketoconazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2, Group A
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Cohort 2, Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Casopitant 150 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Other Intervention Name(s)
Casopitant
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Casopitant 150 mg matching placebo
Intervention Description
Casopitant 150 mg matching placebo will be available as white, film-coated tablets.
Intervention Type
Drug
Intervention Name(s)
Casopitant 50 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Casopitant 50 mg matching placebo
Intervention Description
Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.
Primary Outcome Measure Information:
Title
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.
Title
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
Title
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 Measure Information:
Title
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)
Title
- Vitals Signs monitored at Screen, Day -1, 4-7 and FU
Time Frame
at Screen, Day -1, 4-7 and FU
Title
- 12 lead ECGs at Screen & FU
Time Frame
at Screen & FU
Title
- Adverse Events Monitoring starting at Day 1
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
GSK Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
20124517
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKV109990
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs