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Clinical Trial Details

Trial ID: L3021
Source ID: NCT01223339
Associated Drug: Ertugliflozin
Title: Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Ertugliflozin|DRUG: Placebo|DRUG: Ertugliflozin|DRUG: Placebo
Outcome Measures: Primary: Maximum plasma concentration (Cmax) of ertugliflozin for the Single Dose Cohort, 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, 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, Up to Day 4 of each treatment period|AUC from Hour 0 to infinity (AUCinf) for ertugliflozin for the Single Dose Cohort, Up to Day 4 of each treatment period|Ertugliflozin half life (t1/2) for the Single Dose Cohort, Up to Day 4 of each treatment period|Apparent clearance (CL/F) of ertugliflozin for the Single Dose Cohort, Up to Day 4 of each treatment period|Apparent volume of distribution (Vz/F) for the Single Dose Cohort, 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, Up to Day 4 of each treatment period|Number of participants who experienced an adverse event (AE) for the Single Dose Cohort, 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, Up to Day 1 of each treatment period|Urinary Glucose Excretion over 24 hours for the Single Dose Cohort, Up to 24 hours postdose (Up to Day 2)|Cmax of ertugliflozin for the Multiple Dose Cohort, Up to Day 10|Tmax of ertugliflozin for the Multiple Dose Cohort, Up to Day 10|AUClast for ertugliflozin for the Multiple Dose Cohort, Up to Day 10|AUCinf for ertugliflozin for the Multiple Dose Cohort, Up to Day 10|t1/2 for the Multiple Dose Cohort, Up to Day 10|CL/F of ertugliflozin for the Multiple Dose Cohort, Up to Day 10|Vz/F for the Multiple Dose Cohort, Up to Day 10|Rac for the Single Dose Cohort, Up to Day 10|Number of participants who experienced an AE for the Multiple Dose Cohort, 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, Up to Day 7|Urinary Glucose Excretion over 24 hours for the Multiple Dose Cohort, Up to 24 hours postdose (Up to Day 8) |
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2011-02
Results First Posted:
Last Update Posted: 2016-05-20
Locations:
URL: https://clinicaltrials.gov/show/NCT01223339