- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209741
Bioavailability of Variably Aged MK-0974 Tablets (MK-0974-038)(COMPLETED)
August 17, 2015 updated by: Merck Sharp & Dohme LLC
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
This study will evaluate the comparative bioavailability of three capsule formulations of MK-0974.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
MK-0974 12MoRT
|
[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
|
Active Comparator: 2
MK-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
|
Active Comparator: 3
MK-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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Through 48 hours postdose
|
Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations
Time Frame: Through 48 hours postdose
|
Through 48 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Through 48 hours postdose
|
Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations
Time Frame: Through 48 hours postdose
|
Through 48 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
September 24, 2010
First Posted (Estimate)
September 27, 2010
Study Record Updates
Last Update Posted (Estimate)
August 18, 2015
Last Update Submitted That Met QC Criteria
August 17, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0974-038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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