A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)

NCT ID: NCT01407276

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-08
• Study Completion Date: 2012-03-23

Brief Summary

This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.

Detailed Description

In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal disease (mild, moderate, or severe renal impairment) based on their estimated glomerular filtration rate (eGFR). Each of these panels will be matched with a corresponding panel of equal number of healthy, age-, race-, BMI- and gender-matched control participants. All panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and urine collection. In Part II, 6 participants with end stage renal disease (ESRD) requiring hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1 month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth. Omarigliptin dose administration will be followed by plasma sampling for both panels.

Conditions

Chronic Renal Insufficiency; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Mild Renal Impairment (Panel A)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 1: Control to Match Panel A (Panel B)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 1: Moderate Renal Impairment (Panel C)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 1: Control to Match Panel C (Panel D)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 1: Severe Renal Impairment (Panel E)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 1: Control to Match Panel E (Panel F)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 2: End-stage Renal Disease needing hemodialysis (Panel G)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Part 2: Control to Match Panel G (Panel H)

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Single oral dose of 3 mg (3 x 1-mg capsules)

Interventions

Omarigliptin

Single oral dose of 3 mg (3 x 1-mg capsules)

Intervention Type: DRUG

Other Intervention Names

MK-3102

Eligibility Criteria

Inclusion Criteria

Impaired Renal Function Subjects:

• Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
• Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation

Healthy Subjects:

• Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
• In general good health

Exclusion Criteria

Impaired Renal Function Subjects:

• Is mentally or legally incapacitated
• Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
• History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
• History of stroke, chronic seizures or major neurological disease
• Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
• History of cancer (Some exceptions apply)
• Regular user of barbiturates or sleep aides
• Consumes excessive amounts of alcohol (more than 2 drinks/day)
• Consumes excessive amounts of caffeinated beverages (more than 6/day)
• Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
• Has a history of significant multiple and/or severe allergies
• Current or history of illicit drug abuse
• Nursing mothers

Healthy Subjects:

• Is mentally or legally incapacitated;
• Has a history of stroke, chronic seizures, or major neurological disorder
• Renal impairment
• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
• Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
• History of cancer (Some exceptions apply)
• Regular user of barbiturates or sleep aides
• Consumes excessive amounts of alcohol (more than 2 drinks/day)
• Consumes excessive amounts of caffeinated beverages (more than 6/day)
• Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
• Has a history of significant multiple and/or severe allergies
• Current or history of illicit drug abuse
• Nursing mothers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis Links

View Document

Other Identifiers

3102-009

Identifier Type: -

Identifier Source: org_study_id