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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00757601
First received: September 22, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK1006
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK1006

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing Adverse Events (AEs) On Study [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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:
  • Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006 [ Time Frame: From pre-dose to 168 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: From pre-dose to 168 hours post-dose ] [ Designated as safety issue: No ]
  • Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose [ Time Frame: From pre-dose to 168 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose [ Time Frame: From pre-dose to 168 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: From pre-dose to 168 hours post-dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)
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.
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

Drug: 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

Experimental: Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)
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.
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

Drug: 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

Experimental: 15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)
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.
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

Drug: 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

Experimental: 15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)
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.
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

Drug: 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

Experimental: 60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / 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.
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

Drug: 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

Experimental: Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg 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
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

Drug: 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

Experimental: 60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg 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.
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

Drug: 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

Experimental: 60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg 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.
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

Drug: 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

Experimental: 140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / 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.
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

Drug: 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

Experimental: Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg 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.
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

Drug: 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

Experimental: 140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg 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
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

Drug: 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

Experimental: 140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg 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.
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

Drug: 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


  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757601

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00757601     History of Changes
Other Study ID Numbers: MK-1006-002, 2008_549
Study First Received: September 22, 2008
Results First Received: July 31, 2012
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014