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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01209741
Enrollment
48
Registered
2010-09-27
Start date
2007-10-31
Completion date
2007-11-30
Last updated
2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

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

Interventions

\[INTERVENTION NAME: MK-0974 12MoRT\] Single dose MK-0974 12MoRT (12 month aged MK-0974 capsules, stored at room temperature) 300 mg in one of three treatment periods

DRUGMK-0974 5Mo5C

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

DRUGMK-0974 12Mo5C

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

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulationsThrough 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulationsThrough 48 hours postdose

Secondary

MeasureTime frame
Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12MoRT and 5Mo5C formulationsThrough 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulationsThrough 48 hours postdose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026