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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00567112
First received: November 30, 2007
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: 10 mg MK-0941 DFC (fasted)
Drug: 10 mg MK-0941 OCT (after meal)
Drug: 10 mg MK-0941 OCT (before meal)
Drug: 10 mg MK-0941 OCT (fasted)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DFC (fasted) Drug: 10 mg MK-0941 DFC (fasted)
single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state
Experimental: OCT (fasted) Drug: 10 mg MK-0941 OCT (fasted)
single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
Experimental: OCT (after meal) 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
Active Comparator: OCT (before 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567112

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: NCT00567112     History of Changes
Other Study ID Numbers: 0941-009, 2007_652, MK-0941-009
Study First Received: November 30, 2007
Results First Received: July 17, 2012
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014