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A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00979459
First received: September 17, 2009
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.


Condition Intervention Phase
Type 2 Diabetes
 Drug: MK-1006 DFC
Drug: MK-1006 FCT
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose ] [ Designated as safety issue: No ]
    AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC

  • Maximum Plasma Concentration (Cmax) for MK-1006 [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose ] [ Designated as safety issue: No ]
    Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC


Secondary Outcome Measures:
  • Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Through 30 days post-dose ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Study Medication Due to an Adverse Event [ Time Frame: up to 8 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1006 80 mg DFC
Participants received a single dose of four 20 mg dry filled capsules of MK-1006
 Drug: MK-1006 DFC
Each dry filled capsule contains 20 mg MK-1006
Experimental: MK-1006 80 mg FCT
Participants received a single dose of two 40 mg film coated tablets of MK-1006
 Drug: MK-1006 FCT
Each film coated tablet contains 40 mg of MK-1006

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • is a male or a female of non-child bearing potential
  • has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s)
  • has been a nonsmoker for at least 6 months

Exclusion Criteria:

  • has a history of stroke, chronic seizures, or major neurological disorder
  • has a history of major endocrine (except T2D), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases
  • has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening
  • has unstable or rapidly progressing diabetic retinopathy and/or neuropathy
  • has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening
  • has glaucoma or is blind
  • has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (Lasik is permitted)
  • has a history of type 1 diabetes
  • has symptomatic coronary artery disease
  • consumes excessive amounts of alcohol and/or caffeine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979459

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00979459     History of Changes
Other Study ID Numbers: MK-1006-010, 2009_663
Study First Received: September 17, 2009
Results First Received: July 12, 2012
Last Updated: September 10, 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 June 17, 2013