Chemotherapy-Induced Nausea and VomitingPhase 1NCT00990821

A Study to Investigate the Safety and Tolerability of MK-0517 in Healthy Subjects (MK-0517-012)

A Phase 1 study testing 90 mg MK-0517 (PS80), 100 mg MK-0517 (PS80) and 100 MK-0517 (PS80) + 2 mg midazolam in people with Chemotherapy-Induced Nausea and Vomiting and Postoperative Nausea and Vomiting, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting
What is being tested?: 90 mg MK-0517 (PS80), 100 mg MK-0517 (PS80) and 100 MK-0517 (PS80) + 2 mg midazolam
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 188 participants
Where: No sites listed yet
Study dates: Jan 2005to Jan 2006
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is neither grossly overweight nor underweight for his/her height and body build
Subject is in good health -Subject is a nonsmoker
Subject is willing to avoid excessive alcohol consumption for the duration of the study
Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Who cannot join

Subject has a history of multiple and/or severe allergies to drugs or food
Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
Subject has an infection, including Human immunodeficiency virus (HIV) infection
Subject is a regular user of any illicit drug
Subject consumes excessive amounts of alcohol
Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
Subject currently uses on a regular basis, any prescription or non prescription medications

About this study

Official title: A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects

This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.

Conditions: Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting
Being tested: 90 mg MK-0517 (PS80), 100 mg MK-0517 (PS80), 100 MK-0517 (PS80) + 2 mg midazolam, 115 mg MK-0517 (PS80), 150 mg MK-0517 (PS80)
Medical subject headings: Vomiting, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

90 mg MK-0517 (PS80)Drug
MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes
100 mg MK-0517 (PS80)Drug
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
100 MK-0517 (PS80) + 2 mg midazolamDrug
MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.
115 mg MK-0517 (PS80)Drug
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
150 mg MK-0517 (PS80)Drug
MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes
40 mg MK-0517 (non-PS80)Drug
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
100 mg MK-0517 (non-PS80)Drug
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
150 mg MK-0517 (Non-PS80)Drug
MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.
PlaceboDrug
Placebo matching MK-0517
40 mg AprepitantDrug
Aprepitant, oral, tablet, single dose
125 mg AprepitantDrug
Aprepitant oral tablet, single dose
2 mg MidazolamDrug
Midazolam oral tablet, single dose

Study groups in NCT00990821
Study group	Role	What they receive
Part I, Panel A	Experimental	100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant Receives: Drug: 100 MK-0517 (PS80) + 2 mg midazolam; Drug: 100 mg MK-0517 (non-PS80); Drug: 150 mg MK-0517 (Non-PS80); Drug: Placebo; Drug: 125 mg Aprepitant
Part I, Panel B	Experimental	100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant Receives: Drug: 100 mg MK-0517 (PS80); Drug: 150 mg MK-0517 (PS80); Drug: Placebo; Drug: 125 mg Aprepitant
Part I, Panel C	Experimental	40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant Receives: Drug: 40 mg MK-0517 (non-PS80); Drug: Placebo; Drug: 40 mg Aprepitant
Part II	Experimental	2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam Receives: Drug: 100 mg MK-0517 (PS80); Drug: 2 mg Midazolam
Part III, Panel 1, Treatment Sequence 1	Experimental	125 mg aprepitant → 90 mg MK-0517 (PS80) Receives: Drug: 90 mg MK-0517 (PS80); Drug: 40 mg MK-0517 (non-PS80); Drug: 125 mg Aprepitant
Part III, Panel 1, Treatment Sequence 2	Experimental	40 mg MK-0517 (non-PS80) → 125 mg aprepitant Receives: Drug: 40 mg MK-0517 (non-PS80); Drug: 125 mg Aprepitant
Part III, Panel 2	Experimental	40 mg MK-0517 (non-PS80) Receives: Drug: 40 mg MK-0517 (non-PS80)
Part IV	Experimental	40 mg MK-0517 (non-PS80 formulation) Receives: Drug: 40 mg MK-0517 (non-PS80)
Part V, Treatment Sequence 1	Experimental	125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation) Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant
Part V, Treatment Sequence 2	Experimental	100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant
Part V, Treatment Sequence 3	Experimental	115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80) Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant
Part V, Treatment Sequence 4	Experimental	125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant
Part V, Treatment Sequence 5	Experimental	100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80) Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant
Part V, Treatment Sequence 6	Experimental	115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant Receives: Drug: 100 mg MK-0517 (PS80); Drug: 115 mg MK-0517 (PS80); Drug: 125 mg Aprepitant

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V
AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.
Measured: Up to 72 Hours Post Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jan 2006

First posted7 Oct 2009 (estimated)
Study startJan 2005
Primary completionDec 2005
Study completionJan 2006

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.
Other trials for Chemotherapy-Induced Nausea and VomitingStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00990821
Sponsor's protocol ID: 0517-012
Other IDs: MK-0517-012
Status last verified: Aug 2015
First submitted: 6 Oct 2009
Last updated: 19 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
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)

All Chemotherapy-Induced Nausea and Vomiting trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects
ClinicalTrials.gov ID: NCT00990821
Acronym / sponsor ID: 0517-012
Conditions: Chemotherapy-Induced Nausea and Vomiting, Postoperative Nausea and Vomiting
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Dec 2005 (actual)
Study completion: Jan 2006 (actual)
First posted: 7 Oct 2009 (estimated)
Results: Posted 12 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 14

Arm	Type	Receives
Part I, Panel A	Experimental	Drug: 100 MK-0517 (PS80) + 2 mg midazolam, Drug: 100 mg MK-0517 (non-PS80), Drug: 150 mg MK-0517 (Non-PS80), Drug: Placebo, Drug: 125 mg Aprepitant100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant
Part I, Panel B	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 150 mg MK-0517 (PS80), Drug: Placebo, Drug: 125 mg Aprepitant100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
Part I, Panel C	Experimental	Drug: 40 mg MK-0517 (non-PS80), Drug: Placebo, Drug: 40 mg Aprepitant40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
Part II	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 2 mg Midazolam2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
Part III, Panel 1, Treatment Sequence 1	Experimental	Drug: 90 mg MK-0517 (PS80), Drug: 40 mg MK-0517 (non-PS80), Drug: 125 mg Aprepitant125 mg aprepitant → 90 mg MK-0517 (PS80)
Part III, Panel 1, Treatment Sequence 2	Experimental	Drug: 40 mg MK-0517 (non-PS80), Drug: 125 mg Aprepitant40 mg MK-0517 (non-PS80) → 125 mg aprepitant
Part III, Panel 2	Experimental	Drug: 40 mg MK-0517 (non-PS80)40 mg MK-0517 (non-PS80)
Part IV	Experimental	Drug: 40 mg MK-0517 (non-PS80)40 mg MK-0517 (non-PS80 formulation)
Part V, Treatment Sequence 1	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
Part V, Treatment Sequence 2	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
Part V, Treatment Sequence 3	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
Part V, Treatment Sequence 4	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
Part V, Treatment Sequence 5	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
Part V, Treatment Sequence 6	Experimental	Drug: 100 mg MK-0517 (PS80), Drug: 115 mg MK-0517 (PS80), Drug: 125 mg Aprepitant115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subject is neither grossly overweight nor underweight for his/her height and body build
Subject is in good health -Subject is a nonsmoker
Subject is willing to avoid excessive alcohol consumption for the duration of the study
Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

Key exclusion criteria (7 listed)

Subject has a history of multiple and/or severe allergies to drugs or food
Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
Subject has an infection, including Human immunodeficiency virus (HIV) infection
Subject is a regular user of any illicit drug
Subject consumes excessive amounts of alcohol

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
90 mg MK-0517 (PS80)MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes	Drug	Part III, Panel 1, Treatment Sequence 1
100 mg MK-0517 (PS80)MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes	Drug	Part I, Panel B, Part II, Part V, Treatment Sequence 1, Part V, Treatment Sequence 2, Part V, Treatment Sequence 3, Part V, Treatment Sequence 4, Part V, Treatment Sequence 5, Part V, Treatment Sequence 6
100 MK-0517 (PS80) + 2 mg midazolamMK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral 2-mg dose of midazolam with MK-0517.	Drug	Part I, Panel A
115 mg MK-0517 (PS80)MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes	Drug	Part V, Treatment Sequence 1, Part V, Treatment Sequence 2, Part V, Treatment Sequence 3, Part V, Treatment Sequence 4, Part V, Treatment Sequence 5, Part V, Treatment Sequence 6
150 mg MK-0517 (PS80)MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes	Drug	Part I, Panel B
40 mg MK-0517 (non-PS80)MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.	Drug	Part I, Panel C, Part III, Panel 1, Treatment Sequence 1, Part III, Panel 1, Treatment Sequence 2, Part III, Panel 2, Part IV
100 mg MK-0517 (non-PS80)MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.	Drug	Part I, Panel A
150 mg MK-0517 (Non-PS80)MK-0517 (Non-PS80) is administered as single IV dose over 30 seconds.	Drug	Part I, Panel A
PlaceboPlacebo matching MK-0517	Drug	Part I, Panel A, Part I, Panel B, Part I, Panel C
40 mg AprepitantAprepitant, oral, tablet, single dose	Drug	Part I, Panel C
125 mg AprepitantAprepitant oral tablet, single dose	Drug	Part I, Panel A, Part I, Panel B, Part III, Panel 1, Treatment Sequence 1, Part III, Panel 1, Treatment Sequence 2, Part V, Treatment Sequence 1, Part V, Treatment Sequence 2, Part V, Treatment Sequence 3, Part V, Treatment Sequence 4, Part V, Treatment Sequence 5, Part V, Treatment Sequence 6
2 mg MidazolamMidazolam oral tablet, single dose	Drug	Part II

Primary outcome

Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V
Time frame: Up to 72 Hours Post Dose
AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.

Results and safety

Results posted to the registry on 12 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part I, Panel A	14	14
Part I, Panel B	16	14
Part I, Panel C	14	14
Part II	8	8
Part III, Panel 1, Treatment Sequence 1	17	14
Part III, Panel 1, Treatment Sequence 2	17	14
Part III, Panel 2	12	11
Part IV	14	14
Part V, Treatment Sequence 1	12	12
Part V, Treatment Sequence 2	14	13
Part V, Treatment Sequence 3	12	9
Part V, Treatment Sequence 4	14	9
Part V, Treatment Sequence 5	12	10
Part V, Treatment Sequence 6	12	11

Primary outcome: Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V

Time frame: Up to 72 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng*hr/mL

Measure	Aprepitant (125 mg) n = 70	MK-0517 (100 mg) n = 68	MK-0517 (115 mg) n = 71
Value	29215 (15731)	24961 (10477)	31724 (14287)

Population analysed: All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group.

Adverse events

Time frame: Up to 30 days after the last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
90 mg MK-0517 (PS80)	0 of 31 (0%)	8 of 31 (25.8%)	Not reported
100 mg MK-0517 (PS80)	0 of 82 (0%)	8 of 82 (9.8%)	Not reported
100 mg MK-0517 (PS80) + 2 mg Midazolam	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
115 mg MK-0517 (PS80)	0 of 66 (0%)	7 of 66 (10.6%)	Not reported
150 mg MK-0517 (PS80)	0 of 12 (0%)	3 of 12 (25%)	Not reported
40 mg MK-0517 (Non-PS80)	0 of 36 (0%)	4 of 36 (11.1%)	Not reported
100 mg MK-0517 (Non-PS80)	0 of 12 (0%)	3 of 12 (25%)	Not reported
150 mg MK-0517 (Non-PS80)	0 of 11 (0%)	6 of 11 (54.5%)	Not reported
Placebo	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
40 mg Aprepitant	0 of 14 (0%)	2 of 14 (14.3%)	Not reported
125 mg Aprepitant	0 of 133 (0%)	6 of 133 (4.5%)	Not reported
2 mg Midazolam	0 of 8 (0%)	2 of 8 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy-Induced Nausea and Vomiting

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
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)

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?

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 5 inclusion and 7 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 19 Aug 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 12 Dec 2013). 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?

Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V (time frame: Up to 72 Hours Post Dose). 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 NCT00990821.

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 19 Aug 2015.