Conditions: Healthy Volunteers
Keywords: Drug therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief summary:
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 (IV) infusion (into the arm vein).

Detailed description:
The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up to 6 participants will receive a single 80 mg dose of \[14C\]-TAK-385 administered as an oral solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385 administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of \[14C\]-TAK-385 (containing not more than 37.0kBq \[1000 nCi\] 14C).

This single centre study will take place in the United Kingdom.

Arms:
arm 1: \[14C\]-TAK-385 80 mg, solution, orally, once on Day 1. arm 2: TAK-385 80 mg, tablets, orally, and \[14C\]-TAK-385 80 μg, infusion, intravenous once on Day 1.

Interventions: intervention 1: [14C]-TAK-385 Oral Solution intervention 2: TAK-385 Tablets intervention 3: [14C]-TAK-385 Solution for Intravenous Infusion
Intervention descriptions: intervention 1: TAK-385 oral radiolabelled solution intervention 2: TAK-385 tablets 2 X 40 mg intervention 3: TAK-385 intravenous (IV) radiolabelled solution

Protocol document: