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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567112

2007_652 (Other Identifier)

MK-0941-009 (Other Identifier)

0941-009

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

DFC (fasted)

Experimental group

Treatment:

Drug: 10 mg MK-0941 DFC (fasted)

OCT (fasted)

Experimental group

Treatment:

Drug: 10 mg MK-0941 OCT (fasted)

OCT (after meal)

Experimental group

Treatment:

Drug: 10 mg MK-0941 OCT (after meal)

OCT (before meal)

Active Comparator group

Treatment:

Drug: 10 mg MK-0941 OCT (before meal)