Clinical trial NCT00830791: A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)
Official title: A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 72 Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
Secondary outcomes:
measure: 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
timeFrame: 72-Hours Post-Dose
measure: Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls
timeFrame: 72-Hours Post-Dose
measure: Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
measure: Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls
timeFrame: 72-Hours Post-Dose
measure: Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 72-Hours Post-Dose
measure: 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
timeFrame: 36-Hours Post-Dose
measure: Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls
timeFrame: 36-Hours Post-Dose
measure: Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls
timeFrame: 36-Hours Post-Dose
measure: CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls
timeFrame: 36-Hours Post-Dose
measure: CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls
timeFrame: 36-Hours Post-Dose
measure: CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls
timeFrame: 36-Hours Post-Dose
measure: 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
timeFrame: Up to 12 Hours Post-Dose
measure: 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
timeFrame: Up to 12 Hours Post-Dose
measure: 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
timeFrame: Up to 12 Hours Post-Dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: