CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Unlabeled ertugliflozin for oral use +2 moredrug
Likely dose
Unlabeled ertugliflozin for oral use 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.

Search/NCT02411929
NCT02411929Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Non-Randomized, 2-Period, Fixed Sequence, Study to Assess the Absolute Bioavailability and Fraction Absorbed of Ertugliflozin in Health Male Subjects Using a 14^C-Microdose Approach

Merck Sharp & Dohme LLC·interventional·Posted Apr 8, 2015·Updated Sep 18, 2018

In Brief

A Phase 1 clinical trial evaluating Unlabeled ertugliflozin for oral use, 14^C-labeled ertugliflozin for IV use, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 8 participants.

Detailed Summary

This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration of 14\^C-labeled ertugliflozin in healthy male participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
CollaboratorsPfizer

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 8, 2015
Enrollment StartOct 29, 2014
Primary CompletionJan 30, 2015
Study CompletionFeb 9, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.2 years ago

Interventions

Unlabeled ertugliflozin for oral usedrug

15 mg oral (3 x 5 mg tablets)

14^C-labeled ertugliflozin for IV usedrug

100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin)

14^C-labeled ertugliflozin for oral usedrug

100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin)