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CompletedNCT00404378Updated Sep 12, 2017

Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]

A Phase 1 interventional study of ketoconazole and casopitant 100 mg in Nausea and Vomiting, Chemotherapy-Induced, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.

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Conditions studied

  • Nausea and Vomiting, Chemotherapy-Induced

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Keywords

  • Healthy subjects
  • Pharmacokinetics
  • Drug interaction
  • Ketoconazole
  • Casopitant
03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 15 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male or females
  • Females must be of non-childbearing potential
  • Adequate organ functions
  • Able to swallow and retain oral medications
  • Able to understand and comply with study requirements
  • Signed ICF

Exclusion criteria

Exclusion Criteria:

  • Clinically relevant abnormality identified on the screening exam or any other medical condition or circumstance making the subject unsuitable for participation in the study.
  • History of drug or other allergy which contraindicates participation.
  • Known immediate hypersensitivity reaction or idiosyncrasy to GW679769 or ketoconazole or drugs chemically related to the study medications.
  • Use of an investigational drug within 28 days preceding the first dose of GW679769 or ketoconazole or participation in another clinical trial within the past 30 days.
  • Blood donation in excess of 1 pint within 56 days prior to first dose of study medication or intends to donate within 30 days of the post-treatment follow-up visit.
  • History of or suspected iron deficiency.
  • Positive stool for occult blood.
  • Pepsinogen level below the lower limit of laboratory reference range (LLRR).
  • Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test.
  • For male subjects, any history of hypogonadism and treatments associated with hypogonadism including radiation therapy to the testicles.
  • For female subjects, a positive serum ß-hCG (beta-human chorionic gonadotropin) pregnancy test.
  • Female subject who is lactating.
  • Positive urine drug screen (UDS) including alcohol.
  • Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
  • Positive urinary cotinine. Subjects must not have used any nicotine-containing products, including nicotine patches or gum, within the past 6 months.
  • Smoking history = 4 packs per day/year or smoked within the past 12 months.
  • History of drug abuse or dependence within the past 6 months.
  • History of alcohol abuse within the past 6 months or alcohol consumption in the past 6 months exceeding study requirements
  • Presence of uncontrolled nausea \& vomiting.
  • Presence of an active infection.
  • Any degree of heart failure as defined by the New York Heart Association functional classification system.
  • Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
  • Use of any prescription or non-prescription drug(s), herbal or dietary supplements or vitamins within 14 days prior to the first dose of study medication.
  • Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pomelos or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi and brussels sprouts, mustard) within 14 days prior to the first dose of study medication.
  • History of cholecystectomy or biliary tract disease.
  • Any serious or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Cohort 1 Treatment Period 1

    Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days.

    Drug: casopitant 100 mg

  • Experimental
    Cohort 1 Treatment Period 2

    Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole.

    Drug: ketoconazole · Drug: casopitant 100 mg

  • Experimental
    Cohort 2 Treatment Period 1

    Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days.

    Drug: Casopitant 50 mg

  • Experimental
    Cohort 2 Treatment Period 2

    Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole.

    Drug: ketoconazole · Drug: Casopitant 50 mg

Interventions

  • Drugketoconazole

    Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

  • Drugcasopitant 100 mg

    Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time

    Also known as: casopitant, ketoconazole

  • DrugCasopitant 50 mg

    Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

06

What researchers measure

Primary outcomes

  1. Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3.

    Time frame: Period 1: Day 1, 2 & 3

  2. Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8.

    Time frame: Period 2: Day 4, 5, 6, 7, & 8.

Secondary outcomes

  1. clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests

    Time frame: throughout the study

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Study locations

1 site
  • GSK Investigational Site
    Lenexa, Kansas 66219, United States
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References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00404378
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 28, 2006
Start date
Oct 20, 2006
Primary completion
Jan 5, 2007
Completion
Jan 5, 2007
Last update
Sep 12, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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