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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01209741
First received: September 24, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

This study will evaluate the comparative bioavailability of three capsule formulations of MK-0974.


Condition Intervention Phase
Migraine
Drug: telcagepant potassium
Drug: MK-0974 5Mo5C
Drug: MK-0974 12Mo5C
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01209741     History of Changes
Other Study ID Numbers: MK-0974-038
Study First Received: September 24, 2010
Last Updated: September 24, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014