CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
[14C]-TAK-385 Oral Solution +2 moredrug
Likely dose
TAK-385 Tablets 40 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/NCT02252354
NCT02252354Phase 1Completed
CompareCT.gov

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

Takeda·interventional·Posted Sep 30, 2014·Updated Oct 27, 2016

In Brief

A Phase 1 clinical trial evaluating [14C]-TAK-385 Oral Solution, TAK-385 Tablets, and 1 other intervention for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 30, 2014
Enrollment StartSep 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.8 years ago

Interventions

[14C]-TAK-385 Oral Solutiondrug

TAK-385 oral radiolabelled solution

TAK-385 Tabletsdrug

TAK-385 tablets 2 X 40 mg

[14C]-TAK-385 Solution for Intravenous Infusiondrug

TAK-385 intravenous (IV) radiolabelled solution