A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults

November 8, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14202
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects in Part A
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).
Drug: Casopitant (GW679769) Oral Tablets
Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
Drug: dexamethasone
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
Drug: ondansetron
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.
Other Names:
  • GW679769 Oral Tablets
  • dexamethasone oral tablets & intravenous
  • ondansetron oral tablets & intravenous
Experimental: Subjects in Part B
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.
Drug: Casopitant (GW679769) Oral Tablets
Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
Drug: dexamethasone
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
Drug: ondansetron
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.
Other Names:
  • GW679769 Oral Tablets
  • dexamethasone oral tablets & intravenous
  • ondansetron oral tablets & intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
checked on Day 1, 2 and/or 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety is evaluated by: Clinical Lab Tests done
Time Frame: at Screening, Day -1 & Followup.
at Screening, Day -1 & Followup.
Vitals Signs taken & Adverse Events monitored
Time Frame: at each visit starting at Day -1.
at each visit starting at Day -1.
12 lead ECGs & Serum Pepsinogen level tests
Time Frame: at Screening & Followup.
at Screening & Followup.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2007

Primary Completion (Actual)

May 15, 2007

Study Completion (Actual)

May 15, 2007

Study Registration Dates

First Submitted

February 16, 2007

First Submitted That Met QC Criteria

February 17, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV100787

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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