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

March 12, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From study drug administration to 72 hours post-administration
Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration
Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration
Half Life (t½) for OCT (Fasted) and DFC (Fasted)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration
Cmax of OCT (Fasted) and OCT (After Meal)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration
Tmax for OCT (Fasted) and OCT (After Meal)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration
t1/2 for OCT (Fasted) and OCT (After Meal)
Time Frame: From study drug administration to 72 hours post-administration
From study drug administration to 72 hours post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0941-009
  • 2007_652 (Other Identifier: Merck Registration ID)
  • MK-0941-009 (Other Identifier: Merck Protocol ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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