Overview

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.