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

Phase 1CompletedNCT01209741

Merck Sharp & Dohme LLC48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine

Interventions

telcagepant potassiumDRUG

\[INTERVENTION NAME: MK-0974 12MoRT\] 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 5Mo5CDRUG

Single dose MK-0974 5Mo5C (5 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods

MK-0974 12Mo5CDRUG

Single dose MK-0974 12Mo5C (12 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations

Time frame: Through 48 hours postdose

Secondary Outcomes

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

Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations

Time frame: Through 48 hours postdose

Data from ClinicalTrials.gov

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