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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209741
• Other study ID #: 0974-038
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2010
• Last updated: August 17, 2015
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations		Through 48 hours postdose	No
Primary	Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations		Through 48 hours postdose	No
Secondary	Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations		Through 48 hours postdose	No
Secondary	Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations		Through 48 hours postdose	No