Phase 1
Completed N=16
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Chemotherapy-Induced Nausea and Vomiting (CINV)
Source: ClinicalTrials.gov NCT01111851 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Brain NK1-receptor Occupancy at 24 Hours Post Dose — 100.40; 100.20 Percent of occupancy
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain NK1-receptor Occupancy at 24 Hours Post Dose |
100.40; 100.20 | — |
| PRIMARY Brain NK1-receptor Occupancy at 48 Hours Post Dose |
98.62; 98.79 | — |
| SECONDARY Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax) |
100.25; 99.99 | — |
| SECONDARY Brain NK1-receptor Occupancy at 120 Hours Post Dose |
59.93; 54.32 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01111851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.