A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: MK-0941 5 mg; Drug: MK-0941 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830791

0941-015

2009_522

Details and patient eligibility

About

This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or nonpregnant female age 18 to 75 years
• Female of childbearing potential on appropriate method of contraception
• Body mass index (BMI) less than or equal to 40 kg/m2
• Participant is in good health
• Participant diagnosed with Type 2 Diabetes
• Participant agrees to follow smoking restrictions
• Willing to follow the study diet restrictions

Exclusion criteria

• Mental or legal incapacitation
• Participant has had kidney removed
• History of Type 1 diabetes
• History of stroke, chronic seizures or major neurological disorder
• History of neoplastic disease
• Nursing mother
• Consumes greater than 4 glasses of alcoholic beverages per day
• Consumes greater than 6 servings of caffeinated beverages per day
• Participant has had surgery or donated 1 unit of blood within 1 month of screening
• Participant has history of recent eye infection within 2 weeks of study drug administration
• Clinically diagnosed with glaucoma or blindness
• Has trauma to one or both eyes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

MK-0941 20 mg Mild Renal Insufficiency

Experimental group

Description:

MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.

Treatment:

Drug: MK-0941 20 mg

MK-0941 20 mg Moderate Renal Insufficiency

Experimental group

Description:

MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.

Treatment:

Drug: MK-0941 20 mg

MK-0941 5 mg Severe Renal Insufficiency

Experimental group

Description:

MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.

Treatment:

Drug: MK-0941 5 mg

MK-0941 20 mg Matched Controls

Experimental group

Description:

MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.

Treatment:

Drug: MK-0941 20 mg

MK-0941 5 mg Matched Controls

Experimental group

Description:

MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.

Treatment:

Drug: MK-0941 5 mg