Bioavailability and ADME of DA-1229 in Healthy Males (QBR117364)
Research type
Research Study
Full title
A Phase I, Open-Label, 2-part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects
IRAS ID
161646
Contact name
Joanne Collier
Contact email
Sponsor organisation
Dong-A ST Co., Ltd.
Eudract number
2014-002681-75
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the study drug, DA-1229, for the potential treatment of Type 2 diabetes.
The study will consist of two parts. The purpose of Part 1 of the study is to look at how the study drug is taken up, broken down and removed from the body when given by mouth (orally) and as a radiolabelled injection into a vein. The level of the drug will be determined from blood samples taken during the period of the study. Approximately 6 healthy male subjects will receive a 5 mg DA-1229 tablet followed by an intravenous injection of 20 µg [14C]-DA-1229.
The purpose of Part 2 of the study is to investigate how the study drug is taken up, broken down and removed from the body when given as a radiolabelled oral (by mouth) solution by measuring the level of the study drug in blood, urine and faecal samples. Approximately 6 healthy male subjects will receive a single oral dose of 5 mg [14C]-DA-1229 oral solution.REC name
HSC REC B
REC reference
14/NI/1065
Date of REC Opinion
26 Aug 2014
REC opinion
Further Information Favourable Opinion