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 participants. The secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in Western healthy participants as compared to Japanese healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state
Placebo tablets to Ertugliflozin administered in the fasted state
Ertugliflozin 25 mg tablets administered once daily in the fed state for 7 days
Maximum plasma concentration (Cmax) of ertugliflozin for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Ertugliflozin half life (t1/2) for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Apparent clearance (CL/F) of ertugliflozin for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Apparent volume of distribution (Vz/F) for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac) for the Single Dose Cohort
Time frame: Up to Day 4 of each treatment period
Number of participants who experienced an adverse event (AE) for the Single Dose Cohort
Time frame: Up to 10 days after the final dose of study drug (Up to Day 11)
Number of participants who discontinued study drug due to an AE for the Single Dose Cohort
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Placebo tablets administered once daily in the fed state for 7 days
Time frame: Up to Day 1 of each treatment period
Urinary Glucose Excretion over 24 hours for the Single Dose Cohort
Time frame: Up to 24 hours postdose (Up to Day 2)
Cmax of ertugliflozin for the Multiple Dose Cohort
Time frame: Up to Day 10
Tmax of ertugliflozin for the Multiple Dose Cohort
Time frame: Up to Day 10
AUClast for ertugliflozin for the Multiple Dose Cohort
Time frame: Up to Day 10
AUCinf for ertugliflozin for the Multiple Dose Cohort
Time frame: Up to Day 10
t1/2 for the Multiple Dose Cohort
Time frame: Up to Day 10
CL/F of ertugliflozin for the Multiple Dose Cohort
Time frame: Up to Day 10
Vz/F for the Multiple Dose Cohort
Time frame: Up to Day 10
Rac for the Single Dose Cohort
Time frame: Up to Day 10
Number of participants who experienced an AE for the Multiple Dose Cohort
Time frame: Up to 10 days after the final dose of study drug (Up to Day 17)
Number of participants who discontinued study drug due to an AE for the Multiple Dose Cohort
Time frame: Up to Day 7
Urinary Glucose Excretion over 24 hours for the Multiple Dose Cohort
Time frame: Up to 24 hours postdose (Up to Day 8)