A study to assess the mass balance of TAK-385 in HVs (QBR117173)
Research type
Research Study
Full title
An Open Label, Single Centre, Two Part Phase I Mass Balance Study to Assess the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of Orally Administered [14C]-TAK-385 in Healthy Male Subjects
IRAS ID
159818
Contact name
Pui Leung
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd.
Eudract number
2014-001564-35
Research summary
TAK-385 is being developed by the sponsor and is undergoing parallel clinical development as a potential treatment for gynaecological conditions in women, such as heavy menstrual bleeding and fibroids, and prostate cancer in men.
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth), or as an oral tablet (by mouth) followed by a radiolabelled intravenous infusion into the arm vein.
The study will consist of 2 parts involving up to 12 healthy male subjects. In Part 1, up to 6 subjects will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral solution. In Part 2, up to 6 subjects will receive a single oral 80mg dose of TAK-385 administered as two 40mg tablets and an 80µg intravenous (into a vein) dose of [14C]-TAK-385
REC name
Wales REC 2
REC reference
14/WA/1087
Date of REC Opinion
3 Sep 2014
REC opinion
Further Information Favourable Opinion