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Clinical Trial Details

Trial ID: L6779
Source ID: NCT02115347
Associated Drug: Ertugliflozin 15 Mg
Title: Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02115347/results
Conditions: Type 2 Diabetes Mellitus|Hepatic Impairment
Interventions: DRUG: Ertugliflozin 15 mg
Outcome Measures: Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin, Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (AUClast)., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin, Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours | Secondary: AUClast for Fraction of Ertugliflozin Unbound in Plasma (AUClast,u), Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) for unbound drug (ertugliflozin only)., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|AUCinf for Fraction of Ertugliflozin Unbound in Plasma (AUCinf,u), Area under the plasma concentration-time profile from time zero extrapolated to infinite time for unbound drug (ertugliflozin only) (AUCinf, u)., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|Maximum Plasma Concentration (Cmax) of Ertugliflozin, Cmax is a measure of the maximum amount of drug in the plasma after the dose is given., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|Cmax for Fraction of Ertugliflozin Unbound in Plasma (Cmax,u), Maximum plasma concentration for unbound drug (ertugliflozin only)., Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|Number of Participants Who Experienced an Adverse Event, An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 19 days
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-09-19
Completion Date: 2015-01-19
Results First Posted: 2018-08-03
Last Update Posted: 2018-08-20
Locations:
URL: https://clinicaltrials.gov/show/NCT02115347