A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00790556|
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : January 20, 2011
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: MK8245 Drug: Comparator: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Placebo Comparator: 2
Drug: Comparator: Placebo
MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs) [ Time Frame: 56 days ]
An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.
Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.
Drug-relatedness was determined by the investigator based on clinical judgement.
- Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14 [ Time Frame: Day 14 of each 14-day Treatment Period ]Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.
- Hepatic Glucose Production (HGP) at Baseline [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790556
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|