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Completed

NCT Number: NCT01209741

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

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telcagepant potassium

Drug

[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

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 27, 2010
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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