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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: 10 mg MK-0941 OCT (before meal); Drug: 10 mg MK-0941 DFC (fasted); Drug: 10 mg MK-0941 OCT (fasted); Drug: 10 mg MK-0941 OCT (after meal)

• Registration Number: NCT00567112
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-04
• Primary Completion: 2008-02
• Study Completion: 2008-04
• Results First Submitted: 2012-07-17
• Results First Submitted QC: 2012-08-02
• Results First Posted: 2012-09-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OCT (before meal)	10 mg MK-0941 OCT (before meal)	-
DFC (fasted)	10 mg MK-0941 DFC (fasted)	-
OCT (fasted)	10 mg MK-0941 OCT (fasted)	-
OCT (after meal)	10 mg MK-0941 OCT (after meal)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
AUC(0-∞) for OCT (Fasted) and OCT (After Meal)	From study drug administration to 72 hours post-administration