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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)

Treatments: Drug: Ondansetron; Drug: Aprepitant 250 mg; Drug: Aprepitant 165 mg; Drug: Dexamethasone (12-8-8-16 mg); Drug: Fosaprepitant 150 mg; Drug: MK0999; Drug: Dexamethasone (12-8-16-16 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111851

0869-183

2010_531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 3 patient groups

Fosaprepitant 150 mg

Experimental group

Description:

Fosaprepitant 150 mg

Treatment:

Drug: Ondansetron

Drug: Dexamethasone (12-8-16-16 mg)

Drug: Fosaprepitant 150 mg

Drug: MK0999

Aprepitant 165 mg

Experimental group

Description:

Aprepitant 165 mg

Treatment:

Drug: Ondansetron

Drug: Dexamethasone (12-8-16-16 mg)

Drug: Aprepitant 165 mg

Drug: MK0999

Aprepitant 250 mg

Experimental group

Description:

Aprepitant 250 mg

Treatment:

Drug: Ondansetron

Drug: Dexamethasone (12-8-8-16 mg)

Drug: Aprepitant 250 mg

Drug: MK0999