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NCT Number: NCT01111851

Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)

This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.

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Key information

Conditions

Chemotherapy-Induced Nausea and Vomiting (CINV) Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg & aprepitant 165 mg reveals that the primary hypothesis will not be supported.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally healthy
  • Female participants must be of non-childbearing potential
  • Non-smoker or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion criteria

  • History of a clinically significant psychiatric disorder over the last 5 to 10 years
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • History of neoplastic disease
  • Excessive consumption of alcohol (3 drinks/day) or caffeinated beverages (6 servings/day)
  • Major surgery, donated or lost 1 unit of blood within 4 weeks
  • Participated in another investigational study within 4 weeks
  • History of significant drug allergy or any clinically significant adverse

experiences related to EMEND™, dexamethasone, or ondansetron

  • History of significant multiple and/or severe allergies
  • History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Current drug/alcohol abuse, or history of such within 2 years
  • Participation in a PET study or other study involving administration of a radioactive substance or ionizing radiation within the prior 12 months
  • Extensive radiological examination within the prior 12 months
  • Magnetizable metal prostheses or devices (Magnetic Resonance Imaging (MRI) hazard)
  • History of claustrophobia

Treatment and study plan

Fosaprepitant 150 mg

Drug

a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal

Other names: MK0517

aprepitant 165 mg

Drug

a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal

Other names: MK0869

Aprepitant 250 mg

Drug

a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal

Other names: MK0869

Dexamethasone (12-8-16-16 mg)

Drug

Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.

Other names: Dexamethasone

Dexamethasone (12-8-8-16 mg)

Drug

Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.

Other names: Dexamethasone

ondansetron

Drug

The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion

MK0999

Drug

I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999)

Primary outcomes

  1. Brain NK1-receptor Occupancy at 24 Hours Post Dose

    Time frame: 24 hours post dose

  2. Brain NK1-receptor Occupancy at 48 Hours Post Dose

    Time frame: 48 hours post dose

Secondary outcomes

  1. Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)

    Time frame: 30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant

  2. Brain NK1-receptor Occupancy at 120 Hours Post Dose

    Time frame: 120 hours post dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

MK0869 and MK0517 Time-on-Target PET Study

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Feb 25, 2015

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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