Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

• Status: Completed
• Trial end date: 2014-10-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Pfizer
• Treatments: Ertugliflozin

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) of approximately 18 to 40 kg/m^2

• Stable renal function

• Male or female not of reproductive potential

• Female of reproductive potential must agree or have their partner agree to use 2 acceptable methods of contraception

• Healthy subjects determined to be healthy by investigator screening

• T2DM participants have a diagnosis of T2DM as per American Diabetes Association guidelines

• T2DM participants to be on a stable anti-hyperglycemic regimen with no new drug or drug dosage within 8 weeks of study participation. Variations in daily dose of insulin up to 10% are permitted.

Exclusion Criteria:

• A positive urine drug screen for drugs of abuse or recreational drugs

• Pregnant or nursing females

• History of abuse of alcohol or illicit drugs

• Significant renal or urinary disease within 6 months of study participation

• History of malignancy within the past 5 years basal cell carcinoma of the skin or cervical cancer in situ

• History of human immunodeficiency virus (HIV)

• History of blood dyscrasias or any disorders causing hemolysis or unstable red blood cells

• Any acute disease state (eg, , vomiting, fever, diarrhea) within 7 days before study participation

• Treatment with an investigational drug within 30 days of study participation

• Use of herbal supplements within 28 days prior to study participation

• Any clinically significant malabsorption condition

• Blood donation (excluding plasma donations) of approximately 1 pint within 56 days prior to study participation

• History of sensitivity to ertugliflozin or other Sodium-Glucose co-Transporter 2 (SGLT2) inhibitors

• History of sensitivity to heparin or heparin-induced thrombocytopenia

• Unwilling or unable to comply with the study Lifestyle Guidelines

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease including clinically relevant and significant drug allergies

• Use of prescription drugs (hormonal methods of birth control are allowed), vitamins and dietary supplements within 7 days of study participation

• For T2DM participants, history of type 1 diabetes mellitus or a history of ketoacidosis

• For T2DM participants, clinically significant electrocardiogram abnormality

• For T2DM participants, history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack within 3 months of study participation

• For T2DM participants, heart failure defined as New York Heart Association Functional Class III-IV

• For T2DM participants, renal allograft recipients

• For T2DM participants, requiring dialysis

• For T2DM participants, strict fluid restriction

• For T2DM participants, urinary incontinence

• For T2DM participants, acute renal disease

• For T2DM participants, significant hepatic, cardiac, or pulmonary disease or clinically nephrotic

• For T2DM participants, prescription and over-the-counter medication that is not taken according to a stable regimen for 7 days before study participation

• For T2DM participants, on metformin should not be enrolled if their baseline renal function is outside the approved product labeling

• For T2DM participants receiving any of the following medications within 7 days of study participation: 1. Other SGLT2 inhibitors (eg, dapagliflozin, canagliflozin, empagliflozin); 2. Other injectable anti-hyperglycemic agents including pramlintide or Glucagon-like peptide-1 (GLP-1) analogues; 3. Any immunosuppressive drugs, including cyclosporine, tacrolimus, sirolimus; 4. Oral corticosteroids (note that inhaled, nasal and topical corticosteroids are permitted); 5. Any potent drug-metabolizing enzyme-inducing drug, including rifampin, phenytoin, and carbamazepine; 6. Probenecid, valproic acid, gemfibrozil.