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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757601
• Other study ID #: 1006-002
• Secondary ID: 2008_549
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2008
• Last updated: February 4, 2016
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK1006
MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose
• Placebo
Placebo capsule to match MK1006 1, 10, and 20 mg. Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg. There will a 7-day interval between each dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events (AEs) On Study	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.	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)	Yes
Primary	Number of Participants Who Discontinued Treatment Due to an AE	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.	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)	Yes
Secondary	Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-8]) After Single Dose MK1006	The AUC(0-8) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.	From pre-dose to 168 hours post-dose	No
Secondary	Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose		From pre-dose to 168 hours post-dose	No
Secondary	Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose		From pre-dose to 168 hours post-dose	No
Secondary	Apparent Terminal Half-Life (T 1/2) of MK1006 After Single 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	From pre-dose to 168 hours post-dose	No
Secondary	Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006	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.	From pre-dose to 168 hours post-dose	No