Clinical trial NCT00757601: A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
Official title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006


Eligibility criteria: Inclusion Criteria:

* Participant is between 18 and 55 years of age. Participants up to 65 years of age may be enrolled in Panels B and C
* Female participants must be postmenopausal or otherwise unable to have children
* Participant has a body mass index (BMI) less than or equal to 42 kg/m\^2 at the screening visit
* Participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. For Panels B and C, participant may be treated with combination oral anti-hyperglycemic medications
* Participant is willing to follow the American Heart Association (AHA) diet and exercise program throughout the study
* Participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start

Exclusion Criteria:

* Participant has a history of stroke, seizures, or other neurological disorders
* Participant has a recent history of eye infection or other inflammatory eye conditions
* Participant has glaucoma or is blind
* Participant has had eye surgery within 6 months of study start (Lasik is permitted)
* Participant has type 1 diabetes
* Participant cannot stop taking any of their current prescription or non-prescription medications during the study
* Participant consumes more than 3 alcoholic beverages per day
* Participant consumes more than 6 caffeinated beverages per day
* Participant has had major surgery or has donated blood within 4 weeks of study start
* Participant has multiple and/or severe allergies to drugs or food

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) On Study
timeFrame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
measure: Number of Participants Who Discontinued Treatment Due to an AE
timeFrame: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Secondary outcomes:
measure: Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
timeFrame: From pre-dose to 168 hours post-dose
measure: Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
timeFrame: From pre-dose to 168 hours post-dose
measure: Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
timeFrame: From pre-dose to 168 hours post-dose
measure: Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
timeFrame: From pre-dose to 168 hours post-dose
measure: Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
timeFrame: From pre-dose to 168 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: