Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 1NCT01111851
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
A Phase 1 study testing Fosaprepitant 150 mg, Aprepitant 165 mg and Aprepitant 250 mg in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- What is being tested?
- Fosaprepitant 150 mg, Aprepitant 165 mg and Aprepitant 250 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: MK0869 and MK0517 Time-on-Target PET Study
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.
Read the detailed 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.
- Being tested
- Fosaprepitant 150 mg, Aprepitant 165 mg, Aprepitant 250 mg, Dexamethasone (12-8-16-16 mg), Dexamethasone (12-8-8-16 mg)
- Keywords
- NK1-receptor occupancy
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosaprepitant 150 mgDrug
Also called MK0517
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 mgDrug
Also called MK0869
a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal
Aprepitant 250 mgDrug
Also called 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
Dexamethasone (12-8-16-16 mg)Drug
Also called Dexamethasone
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)Drug
Also called 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.
OndansetronDrug
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
MK0999Drug
I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999)
| Study group | Role | What they receive |
|---|---|---|
| Fosaprepitant 150 mg | Experimental | Fosaprepitant 150 mg Receives: Drug: Fosaprepitant 150 mg; Drug: Dexamethasone (12-8-16-16 mg); Drug: Ondansetron; Drug: MK0999 |
| Aprepitant 165 mg | Experimental | Aprepitant 165 mg Receives: Drug: Aprepitant 165 mg; Drug: Dexamethasone (12-8-16-16 mg); Drug: Ondansetron; Drug: MK0999 |
| Aprepitant 250 mg | Experimental | Aprepitant 250 mg Receives: Drug: Aprepitant 250 mg; Drug: Dexamethasone (12-8-8-16 mg); Drug: Ondansetron; Drug: MK0999 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain NK1-receptor Occupancy at 24 Hours Post Dose
Measured: 24 hours post dose
Brain NK1-receptor Occupancy at 48 Hours Post Dose
Measured: 48 hours post dose
Secondary outcomes (2)
Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)
Measured: 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
Measured: 120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111851
- Sponsor's protocol ID
- 0869-183
- Other IDs
- 2010_531
- Status last verified
- Feb 2015
- First submitted
- 26 Apr 2010
- Last updated
- 25 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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, Shadle CR. Equivalent dynamic human brain NK1-receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012 Aug;92(2):243-50. doi: 10.1038/clpt.2012.62. Epub 2012 Jun 27.
PubMed 22739139
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MK0869 and MK0517 Time-on-Target PET Study
- ClinicalTrials.gov ID
- NCT01111851
- Acronym / sponsor ID
- 0869-183
- Keywords
- NK1-receptor occupancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 3 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fosaprepitant 150 mg | Experimental | Drug: Fosaprepitant 150 mg, Drug: Dexamethasone (12-8-16-16 mg), Drug: Ondansetron, Drug: MK0999Fosaprepitant 150 mg |
| Aprepitant 165 mg | Experimental | Drug: Aprepitant 165 mg, Drug: Dexamethasone (12-8-16-16 mg), Drug: Ondansetron, Drug: MK0999Aprepitant 165 mg |
| Aprepitant 250 mg | Experimental | Drug: Aprepitant 250 mg, Drug: Dexamethasone (12-8-8-16 mg), Drug: Ondansetron, Drug: MK0999Aprepitant 250 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosaprepitant 150 mgAlso: MK0517a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal | Drug | Fosaprepitant 150 mg |
| Aprepitant 165 mgAlso: MK0869a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal | Drug | Aprepitant 165 mg |
| Aprepitant 250 mgAlso: MK0869a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal | Drug | Aprepitant 250 mg |
| Dexamethasone (12-8-16-16 mg)Also: DexamethasoneDexamethasone 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. | Drug | Aprepitant 165 mg, Fosaprepitant 150 mg |
| Dexamethasone (12-8-8-16 mg)Also: DexamethasoneDexamethasone 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. | Drug | Aprepitant 250 mg |
| OndansetronThe 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 | Drug | Aprepitant 165 mg, Aprepitant 250 mg, Fosaprepitant 150 mg |
| MK0999I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999) | Drug | Aprepitant 165 mg, Aprepitant 250 mg, Fosaprepitant 150 mg |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22739139Van 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, Shadle CR. Equivalent dynamic human brain NK1-receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012 Aug;92(2):243-50. doi: 10.1038/clpt.2012.62. Epub 2012 Jun 27.
Related trials for Chemotherapy-Induced Nausea and Vomiting (CINV)
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
RecruitingPhase 2
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy
Not yet recruitingPhase 1
QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration
Chemotherapy-Induced Nausea and Vomiting (CINV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fosaprepitant 150 mg, Aprepitant 165 mg and Aprepitant 250 mg in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain NK1-receptor Occupancy at 24 Hours Post Dose (time frame: 24 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01111851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.