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

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ClinicalTrials.gov Identifier: NCT01209741
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the comparative bioavailability of three capsule formulations of MK-0974.

Condition or disease Intervention/treatment Phase
Migraine Drug: telcagepant potassium Drug: MK-0974 5Mo5C Drug: MK-0974 12Mo5C Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Primary Completion Date : November 2007
Study Completion Date : November 2007
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
MK-0974 12MoRT
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
Active Comparator: 2
MK-0974 5Mo5C
Drug: MK-0974 5Mo5C
Single dose MK-0974 5Mo5C (5 month aged MK-0974 capsules, stored at 5 °C) 300 mg in one of three treatment periods
Active Comparator: 3
MK-0974 12Mo5C
Drug: MK-0974 12Mo5C
Single dose MK-0974 12Mo5C (12 month aged MK-0974 capsules, stored at 5 °C) 300 mg in one of three treatment periods


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ]

Secondary Outcome Measures :
  1. 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 ]
  2. Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations [ Time Frame: Through 48 hours postdose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01209741     History of Changes
Other Study ID Numbers: 0974-038
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015