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Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00567112
First received: November 30, 2007
Last updated: September 12, 2012
Last verified: September 2012
History of Changes

November 30, 2007
September 12, 2012
November 2007
February 2008   (final data collection date for primary outcome measure)
  • Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • Half Life (t½) for OCT (Fasted) and DFC (Fasted) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00567112 on ClinicalTrials.gov Archive Site
  • AUC(0-∞) for OCT (Fasted) and OCT (After Meal) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • Cmax of OCT (Fasted) and OCT (After Meal) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • Tmax for OCT (Fasted) and OCT (After Meal) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
  • t1/2 for OCT (Fasted) and OCT (After Meal) [ Time Frame: From study drug administration to 72 hours post-administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009 AM1)
An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT formulation.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: 10 mg MK-0941 DFC (fasted)
    single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
  • Drug: 10 mg MK-0941 OCT (after meal)
    single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal
  • Drug: 10 mg MK-0941 OCT (before meal)
    single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast
  • Drug: 10 mg MK-0941 OCT (fasted)
    single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
  • Experimental: DFC (fasted)
    Intervention: Drug: 10 mg MK-0941 DFC (fasted)
  • Experimental: OCT (fasted)
    Intervention: Drug: 10 mg MK-0941 OCT (fasted)
  • Experimental: OCT (after meal)
    Intervention: Drug: 10 mg MK-0941 OCT (after meal)
  • Active Comparator: OCT (before meal)
    Intervention: Drug: 10 mg MK-0941 OCT (before meal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females (of non-childbearing potential) between the ages of 18 to 70
  • Participants have been diagnosed with Type 2 Diabetes
  • Participants are nonsmokers for at least 6 months

Exclusion Criteria:

  • Participant should not be diagnosed with Type 1 diabetes
  • Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
  • Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
  • Participant has been diagnosed with glaucoma or is blind
  • Participant has had trauma to one or both eyes
  • Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
  • Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00567112
0941-009, 2007_652, MK-0941-009
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
September 2012

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