Back to resultsA Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron 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 (GW679769) Oral Tablets
dexamethasone
ondansetron
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring GW679769,, Casopitant,, Dexamethasone,, Healthy Human Volunteer, Ondansetron,
Eligibility Criteria
Inclusion Criteria:
- Healthy adult males or females
- Age: 18 to 55 years, inclusive
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ systems function
- Able to swallow and retain oral medication
- Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Exclusion Criteria:
- Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
- Use of an investigation drug within 28 days or 5 half-lives.
- 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.
- Presence of or suspected iron deficiency
- Positive stool for occult blood
- Female subject who is lactating
- 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
- Positive purified protein derivative (PPD) skin test for tuberculosis
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Subjects in Part A
Subjects in Part B
Arm Description
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
Outcomes
Primary Outcome Measures
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
Secondary Outcome Measures
Safety is evaluated by: Clinical Lab Tests done
Vitals Signs taken & Adverse Events monitored
12 lead ECGs & Serum Pepsinogen level tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437229
Brief Title
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
Official Title
An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 19, 2007 (Actual)
Primary Completion Date
May 15, 2007 (Actual)
Study Completion Date
May 15, 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
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
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,, Casopitant,, Dexamethasone,, Healthy Human Volunteer, Ondansetron,
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects in Part A
Arm Type
Experimental
Arm Description
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
Arm Title
Subjects in Part B
Arm Type
Experimental
Arm Description
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
Intervention Type
Drug
Intervention Name(s)
Casopitant (GW679769) Oral Tablets
Intervention Description
Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
Intervention Type
Drug
Intervention Name(s)
ondansetron
Other Intervention Name(s)
GW679769 Oral Tablets, dexamethasone oral tablets & intravenous, ondansetron oral tablets & intravenous
Intervention Description
Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
Primary Outcome Measure Information:
Title
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
Time Frame
checked on Day 1, 2 and/or 3
Secondary Outcome Measure Information:
Title
Safety is evaluated by: Clinical Lab Tests done
Time Frame
at Screening, Day -1 & Followup.
Title
Vitals Signs taken & Adverse Events monitored
Time Frame
at each visit starting at Day -1.
Title
12 lead ECGs & Serum Pepsinogen level tests
Time Frame
at Screening & Followup.
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:
Healthy adult males or females
Age: 18 to 55 years, inclusive
A female subject who is non-childbearing potential or using acceptable contraceptive methods.
Adequate organ systems function
Able to swallow and retain oral medication
Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Exclusion Criteria:
Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
Use of an investigation drug within 28 days or 5 half-lives.
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.
Presence of or suspected iron deficiency
Positive stool for occult blood
Female subject who is lactating
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
Positive purified protein derivative (PPD) skin test for tuberculosis
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
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19205755
Citation
Johnson B, Adams L, Lu E, Zhang K, Lebowitz P, Lates C, Blum R. Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone. Support Care Cancer. 2009 Sep;17(9):1177-85. doi: 10.1007/s00520-008-0571-5. Epub 2009 Feb 10.
Results Reference
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A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
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