Bioavailability of Variably Aged MK-0974 Tablets (MK-0974-038)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01209741

First received: September 24, 2010

Last updated: NA

Last verified: September 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	September 24, 2010
Last Updated Date	September 24, 2010
Start Date ^ICMJE	October 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 24, 2010)	Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ] [ Designated as safety issue: No ] Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: September 24, 2010)	Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ] [ Designated as safety issue: No ] Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Variably Aged MK-0974 Tablets (MK-0974-038)(COMPLETED)
Official Title ^ICMJE	An Open Label, Randomized, 3-Period Crossover Study to Evaluate the Comparative Bioavailability of Variably Aged MK-0974 Capsules Administered Orally as Single Doses in Healthy Male and Female Subjects
Brief Summary	This study will evaluate the comparative bioavailability of three capsule formulations of MK-0974.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: telcagepant potassium [INTERVENTION NAME: MK-0974 12MoRT] Single dose MK-0974 12MoRT (12 month aged MK-0974 capsules, stored at room temperature) 300 mg in one of three treatment periods Drug: MK-0974 5Mo5C Single dose MK-0974 5Mo5C (5 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods Drug: MK-0974 12Mo5C Single dose MK-0974 12Mo5C (12 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods
Study Arm (s)	Active Comparator: 1 MK-0974 12MoRT Intervention: Drug: telcagepant potassium Active Comparator: 2 MK-0974 5Mo5C Intervention: Drug: MK-0974 5Mo5C Active Comparator: 3 MK-0974 12Mo5C Intervention: Drug: MK-0974 12Mo5C
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	November 2007
Primary Completion Date	November 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject is in good health Subject is a nonsmoker Subject is willing to comply with the study restrictions Exclusion Criteria: Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of cancer Subject is a nursing mother Subject has or has a history of any illness that might make participation in the study unsafe or confound the results of the study
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01209741
Other Study ID Numbers ^ICMJE	MK-0974-038
Has Data Monitoring Committee	Not Provided
Responsible Party	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp.
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top