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

• Status: Completed
• Trial end date: 2012-03-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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