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

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ClinicalTrials.gov Identifier: NCT01948986
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

September 20, 2013
September 24, 2013
November 2, 2015
October 2013
October 2014   (Final data collection date for primary outcome measure)
  • 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 ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 19 ]
Same as current
Complete list of historical versions of study NCT01948986 on ClinicalTrials.gov Archive Site
Urinary Glucose Excretion Over 24 Hours (UGE0-24hr) [ Time Frame: Up to 24 hours ]
Same as current
Not Provided
Not Provided
 
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Impairment
  • Type 2 Diabetes Mellitus
Drug: Ertugliflozin
Single oral administration of tablets.
Other Name: MK-8835
  • Experimental: T2DM with No Renal Impairment
    Participants with T2DM and with no renal impairment
    Intervention: Drug: Ertugliflozin
  • Experimental: T2DM with Mild Renal Impairment
    Participants with T2DM and with mild renal impairment
    Intervention: Drug: Ertugliflozin
  • Experimental: T2DM with Moderate Renal Impairment
    Participants with T2DM and with moderate renal impairment
    Intervention: Drug: Ertugliflozin
  • Experimental: T2DM with Severe Renal Impairment
    Participants with T2DM and with severe (not on dialysis) renal impairment
    Intervention: Drug: Ertugliflozin
  • Experimental: Healthy Participants with No Renal Impairment
    Healthy participants with no renal impairment
    Intervention: Drug: Ertugliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
40
October 2014
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01948986
8835-009
B1521023 ( Other Identifier: Pfizer protocol number )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Not Provided
Merck Sharp & Dohme Corp.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP