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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK1006
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)

    Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)

    15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)

    15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)

    60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo

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

    60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006

    60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006

    140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo

    Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006

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

    140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006

    Arm Description

    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.

    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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
    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
    Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
    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
    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.

    Full Information

    First Posted
    September 22, 2008
    Last Updated
    February 4, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00757601
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    15 mg MK1006/Placebo/45 mg MK1006/60 mg MK1006/Placebo (Fed)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo/ 80mg MK1006/ 100mg MK1006/ 120mg MK1006/ 140mg MK1006
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    60mg MK1006/ 80mg MK1006/ Placebo/ 120mg MK1006/ 140mg MK1006
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    60mg MK1006/ 80mg MK1006/ 100mg MK1006/ Placebo/ 140mg MK1006
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo/170mg MK1006/ 200mg MK1006/ 230mg MK1006/ 260mg MK1006
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    140mg MK1006/170mg MK1006/ Placebo/ 230mg MK1006/ 260mg MK1006
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    140mg MK1006/170mg MK1006/ 200mg MK1006/ Placebo/ 260mg MK1006
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    MK1006
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Number of Participants Experiencing Adverse Events (AEs) On Study
    Description
    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.
    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)
    Title
    Number of Participants Who Discontinued Treatment Due to an AE
    Description
    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.
    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)
    Secondary Outcome Measure Information:
    Title
    Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
    Description
    The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
    Time Frame
    From pre-dose to 168 hours post-dose
    Title
    Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
    Time Frame
    From pre-dose to 168 hours post-dose
    Title
    Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
    Time Frame
    From pre-dose to 168 hours post-dose
    Title
    Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
    Description
    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
    Time Frame
    From pre-dose to 168 hours post-dose
    Title
    Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
    Description
    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.
    Time Frame
    From pre-dose to 168 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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