Chemotherapy-Induced Nausea and VomitingPhase 1NCT00945321

A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

A Phase 1 study testing aprepitant 165 mg, Comparator: aprepitant 185 mg and Comparator: fosaprepitant 150 mg in people with Chemotherapy-Induced 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

This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chemotherapy-Induced Nausea and Vomiting
What is being tested?: aprepitant 165 mg, Comparator: aprepitant 185 mg and Comparator: fosaprepitant 150 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: 42 participants
Where: No sites listed yet
Study dates: Feb 2009to Mar 2009
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 in good health
Subject is a nonsmoker
Subject is willing to comply with the study restrictions

Who cannot join

Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
Subject has a history of stroke, seizures, or major neurological disorder
Subject has a history of cancer
Subject consumes more than two alcoholic drinks per day
Subject consumes more than three caffeinated beverages daily

About this study

Official title: A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects

Conditions: Chemotherapy-Induced Nausea and Vomiting
Being tested: aprepitant 165 mg, Comparator: aprepitant 185 mg, Comparator: fosaprepitant 150 mg, Comparator: aprepitant with food
Medical subject headings: Vomiting

What participants receive

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

aprepitant 165 mgDrug
Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
Comparator: aprepitant 185 mgDrug
Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
Comparator: fosaprepitant 150 mgDrug
Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
Comparator: aprepitant with foodDrug
Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Study groups in NCT00945321
Study group	Role	What they receive
1	Active comparator	aprepitant 165 mg Receives: Drug: aprepitant 165 mg
2	Active comparator	aprepitant 185 mg Receives: Drug: Comparator: aprepitant 185 mg
3	Experimental	fosaprepitant 150 mg Receives: Drug: Comparator: fosaprepitant 150 mg
4	Experimental	aprepitant with food Receives: Drug: Comparator: aprepitant with food

What is being measured

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

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg
Measured: Through 72 Hours Postdose
Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.
Measured: Through 72 Hours Postdose

Timeline

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

Feb 2009Mar 2009

First posted24 Jul 2009 (estimated)
Study startFeb 2009
Primary completionMar 2009
Study completionMar 2009

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 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: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00945321
Sponsor's protocol ID: 0869-165
Other IDs: 2009_624, MK-0869-165
Status last verified: Jan 2015
First submitted: 23 Jul 2009
Last updated: 28 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Shadle CR, Murphy MG, Liu Y, Ho M, Tatosian D, Li SX, Blum RA. A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects. Clin Pharmacol Drug Dev. 2012 Jul;1(3):93-101. doi: 10.1177/2160763X12447304.
PubMed 27121336

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 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects
ClinicalTrials.gov ID: NCT00945321
Acronym / sponsor ID: 0869-165
Conditions: Chemotherapy-Induced Nausea and Vomiting
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 24 Jul 2009 (estimated)
Results: Posted 30 Jun 2010

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: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Active comparator	Drug: aprepitant 165 mgaprepitant 165 mg
2	Active comparator	Drug: Comparator: aprepitant 185 mgaprepitant 185 mg
3	Experimental	Drug: Comparator: fosaprepitant 150 mgfosaprepitant 150 mg
4	Experimental	Drug: Comparator: aprepitant with foodaprepitant with food

Who may qualify

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

Key inclusion criteria (3 listed)

Subject is in good health
Subject is a nonsmoker
Subject is willing to comply with the study restrictions

Key exclusion criteria (5 listed)

Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
Subject has a history of stroke, seizures, or major neurological disorder
Subject has a history of cancer
Subject consumes more than two alcoholic drinks per day
Subject consumes more than three caffeinated beverages daily

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
aprepitant 165 mgSingle dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.	Drug	1
Comparator: aprepitant 185 mgSingle dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.	Drug	2
Comparator: fosaprepitant 150 mgSingle dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.	Drug	3
Comparator: aprepitant with foodSingle dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.	Drug	4

Primary outcome

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg
Time frame: Through 72 Hours Postdose
Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.
Time frame: Through 72 Hours Postdose

Results and safety

Results posted to the registry on 30 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A/B/C/D	7	7
B/C/A/D	7	7
C/A/B/D	7	7
A/C/B/E	7	7
B/A/C/E	7	6
C/B/A/E	7	7

Primary outcome: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg

Time frame: Through 72 Hours Postdose. Mean (Standard Deviation). Unit: ng•hr/mL

Measure	165 mg Aprepitant (Fasted State) n = 41	185 mg Aprepitant (Fasted State) n = 41	150 mg Fosaprepitant Dimeglumine (Fasted State) n = 41	165 mg Aprepitant (Light) n = 9	165 mg Aprepitant (High-Fat) n = 12	185 mg Aprepitant (Light) n = 9	185 mg Aprepitant (High-Fat) n = 11
Value	34589 (39.7)	39053 (37.5)	37375 (39.5)	37795 (48.4)	50172 (22.0)	51146 (27.2)	60578 (57.5)

165 mg Aprepitant (Fasted State) vs 150 mg Fosaprepitant Dimeglumine (Fasted State): Least-Squares Mean Ratio: 0.93 (95% CI 0.84 to 1.02), p = 0.001, two one-sided tests
185 mg Aprepitant (Fasted State) vs 150 mg Fosaprepitant Dimeglumine (Fasted State): Least-Squares Mean Ratio: 1.05 (95% CI 0.96 to 1.15), p <0.001, two one-sided tests
165 mg Aprepitant (Fasted State) vs 165 mg Aprepitant (High-Fat): Least-Squares Mean Ratio: 1.47 (90% CI 1.23 to 1.76)

Population analysed: All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.

Primary outcome: Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.

Time frame: Through 72 Hours Postdose. Mean (Standard Error). Unit: ng/mL

Measure	165 mg Aprepitant (Fasted State) n = 41	185 mg Aprepitant (Fasted State) n = 41	165 mg Aprepitant (Light) n = 9	165 mg Aprepitant (High-Fat) n = 12	185 mg Aprepitant (Light) n = 9	185 mg Aprepitant (High-Fat) n = 11
Value	1738 (30.8)	1636 (31.2)	1870 (33.3)	2362 (38.5)	2116 (14.8)	1995 (35.2)

165 mg Aprepitant (Fasted State) vs 165 mg Aprepitant (High-Fat): Least-Squares Mean Ratio: 1.33 (90% CI 1.13 to 1.56)
165 mg Aprepitant (Fasted State) vs 165 mg Aprepitant (Light): Least-Squares Mean Ratio: 1.04 (95% CI 0.86 to 1.25)
185 mg Aprepitant (Fasted State) vs 185 mg Aprepitant (High-Fat): Least-Squares Mean Ratio: 1.14 (90% CI 0.96 to 1.34)

Population analysed: All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
165 mg Aprepitant	0 of 41 (0%)	12 of 41 (29.3%)	Not reported
185 mg Aprepitant	1 of 42 (2.4%)	13 of 42 (31%)	Not reported
150 mg Fosaprepitant Dimeglumine	0 of 41 (0%)	15 of 41 (36.6%)	Not reported
165 mg Aprepitant (Fed State)	0 of 21 (0%)	6 of 21 (28.6%)	Not reported
185 mg Aprepitant (Fed State)	0 of 20 (0%)	3 of 20 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27121336Shadle CR, Murphy MG, Liu Y, Ho M, Tatosian D, Li SX, Blum RA. A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects. Clin Pharmacol Drug Dev. 2012 Jul;1(3):93-101. doi: 10.1177/2160763X12447304.

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?

A Phase 1 study testing aprepitant 165 mg, Comparator: aprepitant 185 mg and Comparator: fosaprepitant 150 mg in people with Chemotherapy-Induced Nausea and Vomiting, 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 5 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 28 Jan 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 30 Jun 2010). 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 Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg (time frame: Through 72 Hours Postdose). 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 NCT00945321, 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 28 Jan 2015.