Absolute bioavailability of ertugliflozin
Research type
Research Study
Full title
A Phase 1, Open-Label, Non-Randomised, 2-Period, Fixed Sequence Study to Assess the Absolute Bioavailability and Fraction Absorbed of Ertugliflozin in Healthy Male Subjects Using a 14C-Microdose Approach
IRAS ID
163105
Contact name
Stuart Mair
Contact email
Sponsor organisation
Merck & Co. Inc.
Eudract number
2014-002700-24
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the study drug, ertugliflozin, for the potential treatment of type 2 diabetes mellitus.
The study will be performed in 2 parts. In the first part, the study will try to identify how much ertugliflozin is taken up by the body when dosed orally (by mouth) compared to when the study drug is given through an intravenous (IV) injection (into a vein). The dose given directly into the vein will be radiolabelled meaning that it contains a radioactive component in order to track where the drug is in the body. In the second part, the study will try to measure how much study drug is taken up by the body when dosed orally (by mouth) as ertugliflozin compared to when the study drug is given orally (by mouth) as radiolabelled ertugliflozin.
In the first part of the study, 8 healthy male volunteers aged 18 to 65 years will receive a single oral dose of 15 milligrams ertugliflozin (3 x 5 mg tablets) followed by a 5 minute IV infusion of 100 micrograms 14C-ertugliflozin. In the second part of the study, the 8 healthy male volunteers will receive a single oral dose of 15 milligrams ertugliflozin (3 x 5 mg tablets) along with a single oral dose of 100 micrograms 14C-ertugliflozin.
REC name
HSC REC A
REC reference
14/NI/1097
Date of REC Opinion
7 Oct 2014
REC opinion
Favourable Opinion