Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01111851

First received: April 26, 2010

Last updated: September 29, 2011

Last verified: September 2011

History of Changes

Results First Received: September 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chemotherapy-Induced Nausea and Vomiting (CINV)
Interventions:	Drug: Fosaprepitant 150 mg Drug: Aprepitant 165 mg Drug: Aprepitant 250 mg Drug: Dexamethasone (12-8-16-16 mg) Drug: Dexamethasone (12-8-8-16 mg) Drug: Ondansetron Drug: MK0999

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Aprepitant 250 mg was not evaluated because the assessment of the positron emission tomography (PET) scan data (neurokinin 1 (NK1)-receptor occupancy values at 24 & 48 hours postdose) from fosaprepitant 150 mg & aprepitant 165 mg revealed that the protocol’s hypothesis was met; therefore, it was not necessary to evaluate aprepitant 250 mg.

Reporting Groups

	Description
Fosaprepitant 150 mg	A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
Aprepitant 165 mg	A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.

Participant Flow: Overall Study

	Fosaprepitant 150 mg	Aprepitant 165 mg
STARTED	8	8
COMPLETED	6	8
NOT COMPLETED	2	0
All planned PET scans were not obtained.	2	0

Baseline Characteristics

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Reporting Groups

	Description
Fosaprepitant 150 mg	A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
Aprepitant 165 mg	A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
Total	Total of all reporting groups

Baseline Measures

	Fosaprepitant 150 mg	Aprepitant 165 mg	Total
Number of Participants [units: participants]	8	8	16
Age, Customized [units: Participants]
< = 18 years	0	0	0
Between 18 and 55 years	8	8	16
> = 55 years	0	0	0
Gender [units: participants]
Female	0	0	0
Male	8	8	16
Region of Enrollment [units: participants]
Belgium	8	8	16

Outcome Measures

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1. Primary:

Brain NK1-receptor Occupancy at 24 Hours Post Dose [ Time Frame: 24 hours post dose ]

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2. Primary:

Brain NK1-receptor Occupancy at 48 Hours Post Dose [ Time Frame: 48 hours post dose ]

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3. Secondary:

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 ]

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4. Secondary:

Brain NK1-receptor Occupancy at 120 Hours Post Dose [ Time Frame: 120 hours post dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01111851 History of Changes
Other Study ID Numbers:	MK-0869-183, 2010_531
Study First Received:	April 26, 2010
Results First Received:	September 29, 2011
Last Updated:	September 29, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

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