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
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: 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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 02, 2014