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Completed

NCT Number: NCT00460707

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Overland Park, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Casopitant 150 mg

Drug

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.

Ketoconazole

Drug

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).

Other names: Casopitant

Casopitant 150 mg matching placebo

Drug

Casopitant 150 mg matching placebo will be available as white, film-coated tablets.

Casopitant 50 mg

Drug

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.

Casopitant 50 mg matching placebo

Drug

Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: Day 4 to 9 of Period 2

Secondary outcomes

  1. 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)

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

    Time frame: at Screen, Day -1, 4-7 and FU

  3. - 12 lead ECGs at Screen & FU

    Time frame: at Screen & FU

  4. - Adverse Events Monitoring starting at Day 1

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 16, 2007
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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