NCT01209741

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

September 24, 2010

Last Update Submit

August 17, 2015

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

  • Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations

    Through 48 hours postdose

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

    Through 48 hours postdose

Secondary Outcomes (2)

  • Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations

    Through 48 hours postdose

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

    Through 48 hours postdose

Study Arms (3)

1

ACTIVE COMPARATOR

MK-0974 12MoRT

Drug: telcagepant potassium

2

ACTIVE COMPARATOR

MK-0974 5Mo5C

Drug: MK-0974 5Mo5C

3

ACTIVE COMPARATOR

MK-0974 12Mo5C

Drug: MK-0974 12Mo5C

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

1
MK-0974 5Mo5CDRUG

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

2
MK-0974 12Mo5CDRUG

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

3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is in good health
  • Subject is a nonsmoker
  • 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 illness that might make participation in the study unsafe or 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 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

September 24, 2010

First Posted

September 27, 2010

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 18, 2015

Record last verified: 2015-08