NCT00965887

Brief Summary

This study will evaluate the bioequivalence of two solid dose formulations of MK0974.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

August 24, 2009

Last Update Submit

July 3, 2015

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

  • Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations

    Through 48 hours postdose

  • Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations

    Through 48 Hours Post Dose

Study Arms (2)

1

ACTIVE COMPARATOR

MK0974 Ethanolate

Drug: MK0974 Ethanolate formulation

2

ACTIVE COMPARATOR

MK0974 Hydrate

Drug: Comparator: MK0974 Hydrate formulation

Interventions

MK0974 Ethanolate formulationDRUG

Single dose MK0974 280 mg tablet in one of two treatment periods

1
Comparator: MK0974 Hydrate formulationDRUG

Single dose MK0974 280 mg tablet in one of two treatment periods

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is in good health
  • Subject is a non-smoker
  • Subject is willing to comply with the study restrictions

You may not qualify if:

  • 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 disease or condition that might make participation in the study unsafe or that might confound the results of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 7, 2015

Record last verified: 2015-07