A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)
Status and phase
Completed
Phase 1
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin
Details and patient eligibility
About
Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.
Enrollment
24 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg
Exclusion criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
24 participants in 6 patient groups
Cohort 1 Sequence 1
Experimental group
Description:
Period 1 (fasted) Placebo → Period 2 (fasted) ertugliflozin (E) 10 mg → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Cohort 1 Sequence 2
Experimental group
Description:
Period 1 (fasted) E 0.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Cohort 1 Sequence 3
Experimental group
Description:
Period 1 (fasted) E 0.5 mg → Period 2 (fasted) E 10 mg → Period 3 (fasted) Placebo → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 1
Experimental group
Description:
Period 1 (fasted) Placebo → Period 2 (fasted) E 30 mg → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 2
Experimental group
Description:
Period 1 (fasted) E 2.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 3
Experimental group
Description:
Period 1 (fasted) E 2.5 mg → Period 2 (fasted) E 30 mg → Period 3 (fasted) Placebo. Each dose of study drug will be separated by a minimum of 7 days.
Treatment:
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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