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

Phase 1

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: MK-0941 5 mg; Drug: MK-0941 20 mg

• Registration Number: NCT00830791
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-28
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2012-05-01
• Results First Submitted QC: 2012-06-07
• Results First Posted: 2012-07-23
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-0941 5 mg Matched Controls	MK-0941 5 mg	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.
MK-0941 5 mg Severe Renal Insufficiency	MK-0941 5 mg	MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.
MK-0941 20 mg Mild Renal Insufficiency	MK-0941 20 mg	MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.
MK-0941 20 mg Matched Controls	MK-0941 20 mg	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.
MK-0941 20 mg Moderate Renal Insufficiency	MK-0941 20 mg	MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.

Primary Outcome Measures

Name	Time	Method
Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	72 Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of \> 50 to 80 mL/min/1.73m\^2.
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.

Secondary Outcome Measures

Name	Time	Method
Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.
Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.
T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.
Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.
Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.
T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls	Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to \< 50 mL/min/1.73m\^2.
Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls	Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2.
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.
Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2.
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls	36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2.
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls	Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.