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

Merck Sharp & Dohme LLC18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

10 mg MK-0941 DFC (fasted)DRUG

single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state

10 mg MK-0941 OCT (after meal)DRUG

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal

10 mg MK-0941 OCT (before meal)DRUG

single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)