At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
[14C]-TAK-954drug
Likely dose
Not stated in 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.
A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male Subjects
In Brief
A Phase 1 clinical trial evaluating [14C]-TAK-954 for Healthy Volunteers. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of \[14C\]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartApr 2018
Primary CompletionJun 2018
TodayJul 2026
First PostedApr 18, 2018
Enrollment StartApr 30, 2018
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.2 years ago
Interventions
[14C]-TAK-954drug
\[14C\]-TAK-954 intravenous infusion.