NCT01948986

Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

A Phase 1, Non-Randomized, Open-Label, Single Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.

Conditions

• Renal Impairment
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ertugliflozin	Single oral administration of 3 X 5 mg tablets.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-10-06
• Completion: 2014-10-16
• First posted: 2013-09-24
• Last updated: 2019-02-18
• Results posted: 2019-02-18

Regulatory

• FDA-regulated drug study