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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFC (fasted)<br> | Drug: 10 mg MK-0941 DFC (fasted)<br>* single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state<br>|
| Experimental: OCT (fasted)<br> | Drug: 10 mg MK-0941 OCT (fasted)<br>* single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state<br>|
| Experimental: OCT (after meal)<br> | Drug: 10 mg MK-0941 OCT (after meal)<br>* single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal<br>|
| Active Comparator: OCT (before meal)<br> | Drug: 10 mg MK-0941 OCT (before meal)<br>* single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted) |  | From study drug administration to 72 hours post-administration | 
| Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted) |  | From study drug administration to 72 hours post-administration | 
| Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted) |  | From study drug administration to 72 hours post-administration | 
| Half Life (t½) for OCT (Fasted) and DFC (Fasted) |  | From study drug administration to 72 hours post-administration | 

Secondary Outcome Measures

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