A Phase 1 interventional study of Fosaprepitant 150 mg and Aprepitant 165 mg in Chemotherapy-Induced Nausea and Vomiting (CINV), sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-25.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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.
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.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's enrollment of 16 is below the median of 105 across 954 interventional studies indexed under Vomiting.
Browse Vomiting studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Exclusion Criteria:
experiences related to EMEND™, dexamethasone, or ondansetron
Fosaprepitant 150 mg
Drug: Fosaprepitant 150 mg · Drug: Dexamethasone (12-8-16-16 mg) · Drug: Ondansetron · Drug: MK0999
Aprepitant 165 mg
Drug: Aprepitant 165 mg · Drug: Dexamethasone (12-8-16-16 mg) · Drug: Ondansetron · Drug: MK0999
Aprepitant 250 mg
Drug: Aprepitant 250 mg · Drug: Dexamethasone (12-8-8-16 mg) · Drug: Ondansetron · Drug: MK0999
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
Also known as: MK0517
a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal
Also known as: MK0869
a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal
Also known as: MK0869
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.
Also known as: Dexamethasone
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.
Also known as: Dexamethasone
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
I.V. infusion of MK0999 containing \~100 MBq (\~3 mCi) containing ≤ 5 ug of MK0999)
Brain NK1-receptor Occupancy at 24 Hours Post Dose
Time frame: 24 hours post dose
Brain NK1-receptor Occupancy at 48 Hours Post Dose
Time frame: 48 hours post dose
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
Brain NK1-receptor Occupancy at 120 Hours Post Dose
Time frame: 120 hours post dose
| Milestone | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Started | 8 | 8 |
| Completed | 6 | 8 |
| Not completed | 2 | 0 |
| Withdrew: All planned pet scans were not obtained. | 2 | 0 |
| Percent of occupancy | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Brain NK1-receptor Occupancy at 24 Hours Post Dose | 100.40 (99.51 to 101.29) | 100.20 (99.31 to 101.09) |
| Percent of occupancy | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Brain NK1-receptor Occupancy at 48 Hours Post Dose | 98.62 (96.91 to 100.37) | 98.79 (97.19 to 100.42) |
| Percent of occupancy | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax) | 100.25 (97.22 to 103.39) | 99.99 (97.47 to 102.58) |
| Percent of occupancy | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Brain NK1-receptor Occupancy at 120 Hours Post Dose | 59.93 (34.37 to 104.49) | 54.32 (31.15 to 94.71) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fosaprepitant 150 mg | — | 0/8 (0%) | 5/8 (62.5%) |
| Aprepitant 165 mg | — | 0/8 (0%) | 8/8 (100%) |
| Event | Fosaprepitant 150 mg | Aprepitant 165 mg |
|---|---|---|
| Abdominal distensionGastrointestinal disorders | 0/8 | 4/8 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 2/8 | 4/8 |
| HiccupsRespiratory, thoracic and mediastinal disorders | 1/8 | 4/8 |
| FlushingVascular disorders | 3/8 | 1/8 |
| DizzinessNervous system disorders | 2/8 | 1/8 |
| HeadacheNervous system disorders | 2/8 | 0/8 |
| Vision blurredEye disorders | 1/8 | 1/8 |
| Visual impairmentEye disorders | 0/8 | 1/8 |
| Abdominal painGastrointestinal disorders | 1/8 | 0/8 |
| ConstipationGastrointestinal disorders | 0/8 | 1/8 |
| Age, Customized(Participants) | Fosaprepitant 150 mg | Aprepitant 165 mg | Total |
|---|---|---|---|
| < = 18 years | 0 | 0 | 0 |
| Between 18 and 55 years | 8 | 8 | 16 |
| > = 55 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Fosaprepitant 150 mg | Aprepitant 165 mg | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 8 | 16 |
| Region of Enrollment(participants) | Fosaprepitant 150 mg | Aprepitant 165 mg | Total |
|---|---|---|---|
| Belgium | 8 | 8 | 16 |
No study locations are listed for this record.
The record gives a start of Apr 2010, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2011, 1 year 1 month after primary completion.
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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fosaprepitant · Aprepitant · Dexamethasone