Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)

• Status: Completed
• Trial end date: 2008-04-10
• Target enrollment: 0
• Participant gender: All

Summary

Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Sumatriptan

Criteria

Inclusion Criteria:

• History of migraine for longer than 6 months.

• Free from migraine 24 hours before each dosing.

• Judged to be in good health.

• Nonsmoker

Exclusion Criteria:

• Under age of legal consent.

• Legally or mentally incapacitated or has significant emotional problems.

• Taking any medications from about 2 weeks before the first dose of study medication.

• Has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening

• Currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years

• Consumes more than 6 caffeinated beverages per day