Status:
COMPLETED
Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy pa...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
- Japanese subjects must have four Japanese grandparents who were born in Japan.
- Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Asian or Polynesian subjects in Western subject groups.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening.
- History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent).
- Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- 12-lead ECG demonstrating QTc \>450 msec at screening.
- Subjects with ANY of the following abnormalities on safety laboratory tests):
- Evidence of glycosuria, as defined by a positive urine dipstick test;
- Fasting serum triglyceride \>300 mg/dL;
- Fasting LDL-cholesterol \> than or equal to 190 mg/dL.
- Fasting serum glucose \>125 mg/dL.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01223339
Start Date
October 1 2010
End Date
February 1 2011
Last Update
May 20 2016
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