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Clinical Trial Details

Trial ID: L5184
Source ID: NCT00989079
Associated Drug: Ertugliflozin
Title: A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ertugliflozin|DRUG: Placebo to Ertugliflozin
Outcome Measures: Primary: Number of Participants Experiencing an Adverse Event (AE), Up to Day 10 of each dosing period|Number of Participants Discontinuing Study Drug Due to an AE, Up to Day 8 of each dosing period|Change from baseline in 24-hour urinary glucose excretion, Baseline and 24 hours|Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin, 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, Up to Day 4 of each treatment period|Maximum plasma concentration (Cmax) of ertugliflozin, Up to Day 4 of each treatment period|Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin, Up to Day 4 of each treatment period|Ertugliflozin half life (t1/2), Up to Day 4 of each treatment period|Apparent clearance (CL/F) after a single dose of ertugliflozin, Up to Day 4 of each treatment period|Apparent volume of distribution (Vz/F), Up to Day 4 of each treatment period | Secondary: Urinary glucose excretion over 72 hours, Up to 72 hours of each dosing period|Change from baseline in 24-hour weighted mean glucose, Baseline and 24 hours|Inhibition of glucose reabsorption, Up to 24 hours of each dosing period|Renal clearance (CLr) of Ertugliflozin, Up to 24 hours of each dosing period|Urinary recovery of Ertugliflozin, Up to 24 hours of each dosing period
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: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2009-10-16
Completion Date: 2009-12-11
Results First Posted:
Last Update Posted: 2020-05-29
Locations:
URL: https://clinicaltrials.gov/show/NCT00989079