Conditions: Type 2 Diabetes Mellitus Hepatic Impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: yes

Brief 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).

Detailed description:

Arms:
arm 1: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin arm 2: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin arm 3: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin

Interventions: intervention 1: Ertugliflozin 15 mg
Intervention descriptions: intervention 1: Tablet

Protocol document: