A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK1006; Drug: Placebo

• Registration Number: NCT00757601
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-08-08
• Results First Posted: 2012-09-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006	Placebo	Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5
Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006	MK1006	Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006	MK1006	Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5
15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)	MK1006	Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo	Placebo	Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006	MK1006	Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006	MK1006	Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)	MK1006	Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)	Placebo	Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)	Placebo	Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo	MK1006	Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006	Placebo	Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006	Placebo	Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)	MK1006	Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)	MK1006	Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)	Placebo	Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)	Placebo	Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006	MK1006	Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5
60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006	Placebo	Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006	Placebo	Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo	MK1006	Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo	Placebo	Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006	Placebo	Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5
140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006	MK1006	Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events (AEs) On Study	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)	An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Number of Participants Who Discontinued Treatment Due to an AE	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)	An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.

Secondary Outcome Measures

Name	Time	Method
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006	From pre-dose to 168 hours post-dose	The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose	From pre-dose to 168 hours post-dose
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose	From pre-dose to 168 hours post-dose
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose	From pre-dose to 168 hours post-dose	The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination
Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006	From pre-dose to 168 hours post-dose	The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.