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

Chemotherapy-Induced Nausea and Vomiting (CINV) Clinical Trial

Official title:

MK0869 and MK0517 Time-on-Target PET Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111851
• Other study ID #: 0869-183
• Secondary ID: 2010_531
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2010
• Last updated: February 6, 2015
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting (CINV)

Intervention

Drug:
• Fosaprepitant 150 mg
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
• Aprepitant 165 mg
a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal
• Aprepitant 250 mg
a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal
• Dexamethasone (12-8-16-16 mg)
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.
• Dexamethasone (12-8-8-16 mg)
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.
• Ondansetron
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
I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing = 5 ug of MK0999)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Van Laere K, De Hoon J, Bormans G, Koole M, Derdelinckx I, De Lepeleire I, Declercq R, Sanabria Bohorquez SM, Hamill T, Mozley PD, Tatosian D, Xie W, Liu Y, Liu F, Zappacosta P, Mahon C, Butterfield KL, Rosen LB, Murphy MG, Hargreaves RJ, Wagner JA, Shadl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain NK1-receptor Occupancy at 24 Hours Post Dose		24 hours post dose	No
Primary	Brain NK1-receptor Occupancy at 48 Hours Post Dose		48 hours post dose	No
Secondary	Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)		30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant	No
Secondary	Brain NK1-receptor Occupancy at 120 Hours Post Dose		120 hours post dose	No