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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01948986
First received: September 20, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Type 2 Diabetes Mellitus
Drug: Ertugliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Non-Randomized, Open-Label, Single Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) [ Time Frame: Up to 96 hours after study drug administration ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 19 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Urinary Glucose Excretion Over 24 Hours (UGE0-24hr) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2DM with No Renal Impairment
Participants with T2DM and with no renal impairment
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835
Experimental: T2DM with Mild Renal Impairment
Participants with T2DM and with mild renal impairment
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835
Experimental: T2DM with Moderate Renal Impairment
Participants with T2DM and with moderate renal impairment
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835
Experimental: T2DM with Severe Renal Impairment
Participants with T2DM and with severe (not on dialysis) renal impairment
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835
Experimental: Healthy Participants with No Renal Impairment
Healthy participants with no renal impairment
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948986

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Call for Information (Investigational Site 1002) Recruiting
Anaheim, California, United States, 92801
United States, Florida
Call for Information (Investigational Site 1004) Recruiting
DeLand, Florida, United States, 32720
Call for Information (Investigational Site 1001) Recruiting
South Miami, Florida, United States, 33143
United States, Minnesota
Call for Information (Investigational Site 1003) Recruiting
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01948986     History of Changes
Other Study ID Numbers: 8835-009, B1521023
Study First Received: September 20, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014