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

September 17, 2009
September 10, 2012
September 2009
November 2009   (final data collection date for primary outcome measure)
  • 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
  • Area under the concentration versus time curve (AUC(0-infinity)) for MK1006 [ Time Frame: Through 120 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of MK1006 [ Time Frame: Through 120 hours post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00979459 on ClinicalTrials.gov Archive Site
  • 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 ]
Incidence of serious and non-serious adverse events [ Time Frame: Through 30 days post-dose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
A Single Dose Study to Compare the Pharmacokinetics of Two Probe Formulations of MK-1006

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: MK-1006 DFC
    Each dry filled capsule contains 20 mg MK-1006
  • Drug: MK-1006 FCT
    Each film coated tablet contains 40 mg of MK-1006
  • Experimental: MK-1006 80 mg DFC
    Participants received a single dose of four 20 mg dry filled capsules of MK-1006
    Intervention: Drug: MK-1006 DFC
  • Experimental: MK-1006 80 mg FCT
    Participants received a single dose of two 40 mg film coated tablets of MK-1006
    Intervention: Drug: MK-1006 FCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00979459
MK-1006-010, 2009_663
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP