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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00979459
First received: September 17, 2009
Last updated: September 10, 2012
Last verified: September 2012
  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:


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

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
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: NCT00979459

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: 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 July 23, 2014