At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Ertugliflozin 15 mgdrug
Likely dose
Ertugliflozin 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Non-randomized, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Hepatic Impairment and the Healthy Subjects With Normal Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Ertugliflozin 15 mg for Type 2 Diabetes Mellitus and Hepatic Impairment. Completed, enrolled 16 participants.
Detailed Summary
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1 of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Hepatic Impairment
Countries--
CollaboratorsPfizer
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartSep 2014
Primary CompletionJan 2015
Study CompletionJan 2015
TodayJul 2026
First PostedApr 16, 2014
Enrollment StartSep 19, 2014
Primary CompletionJan 10, 2015
Study CompletionJan 19, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.2 years ago
Interventions
Ertugliflozin 15 mgdrug
Tablet