Last updated: 11/04/2018 09:51:04

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

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GSK study ID
NKV109990
See study documents
Clinicaltrials.gov ID
NCT00460707
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Plasma levels of casopitant and ketoconazole will be checked on Day 4 to 9 in Cohort 1.

Timeframe: Day 4 to 9 in Cohort 1.

Plasma levels of casopitant will be checked on Day 2 to 4 of Period 1 and

Timeframe: Day 2 to 4 of Period 1

casopitant and ketoconazole will be checked on Day 4 to 9 of Period 2.

Timeframe: Day 4 to 9 of Period 2

Secondary outcomes:

Safety is evaluated in Cohort 1 by: - Clinical Lab Tests & Physical Exam at Screen, Day -1 & Followup (FU)

Timeframe: at Screen, Day -1 & Followup (FU)

- Vitals Signs monitored at Screen, Day -1, 4-7 and FU

Timeframe: at Screen, Day -1, 4-7 and FU

- 12 lead ECGs at Screen & FU

Timeframe: at Screen & FU

- Adverse Events Monitoring starting at Day 1

Timeframe: Day 1

Interventions:
  • Drug: Casopitant 150 mg
  • Drug: Ketoconazole
  • Drug: Casopitant 150 mg matching placebo
  • Drug: Casopitant 50 mg
  • Drug: Casopitant 50 mg matching placebo
    • Enrollment:
    85
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Johnson BM; Adams LM; Zhang K; Gainer SD; Kirby LC; Blum PA; Apseloff G; Morrison RA; Shutz 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.
    Johnson BM; Adams LM; Zhang K; Gainer SD; Kirby LC; Blum PA; Apseloff G; Morrison RA; Shutz 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.
    Medical condition
    Nausea and Vomiting, Chemotherapy-Induced
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to August 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • A female subject who is non-childbearing potential or using acceptable contraceptive methods.
    • Adequate organ system functions.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Buffalo, New York, United States, 14202
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-27-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 109990 can be found on the GSK Clinical Study Register.
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