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

NCT00830791 | Terminated Phase 1 Results

• 2 other identifiers: 0941-0152009_522
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  72 Hours Post-Dose

• 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

  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.

  72-Hours Post-Dose

• 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

  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.

  72-Hours Post-Dose

Secondary Outcomes (18)

• 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 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 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

• 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 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

Study Arms (5)

MK-0941 20 mg Mild Renal Insufficiency

EXPERIMENTAL

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

Drug: MK-0941 20 mg

MK-0941 20 mg Moderate Renal Insufficiency

EXPERIMENTAL

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

Drug: MK-0941 20 mg

MK-0941 5 mg Severe Renal Insufficiency

EXPERIMENTAL

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

Drug: MK-0941 5 mg

MK-0941 20 mg Matched Controls

EXPERIMENTAL

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.

Drug: MK-0941 20 mg

MK-0941 5 mg Matched Controls

EXPERIMENTAL

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.

Drug: MK-0941 5 mg

Interventions

MK-0941 20 mg DRUG

Two 10-mg tablets of MK-0941 administered as a single oral dose.

MK-0941 20 mg Matched Controls; MK-0941 20 mg Mild Renal Insufficiency; MK-0941 20 mg Moderate Renal Insufficiency

MK-0941 5 mg DRUG

MK-0941 administered as one single 5-mg tablet.

MK-0941 5 mg Matched Controls; MK-0941 5 mg Severe Renal Insufficiency

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

(800) 672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 26, 2015
• Results First Posted: July 23, 2012

Record last verified: 2015-02