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Completed

NCT Number: NCT00757601

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK1006

Drug

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

Drug

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 outcomes

  1. 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)

    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.

  2. 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)

    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 outcomes

  1. 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

    The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

  2. Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose

    Time frame: From pre-dose to 168 hours post-dose

  3. Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose

    Time frame: From pre-dose to 168 hours post-dose

  4. Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose

    Time frame: 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

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2008
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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