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Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants

Opioid Use Disorder Clinical Trial

Official title:
A Phase I, Open Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Dose of Oral [14C]-IDV184001AN in Healthy Adult Male Participants

Clinical Trial Summary

The purpose of this open label study is to characterise the absorption, metabolism, excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male participants.

Clinical Trial Description

The study is designed as an open label, single-dose study in healthy adult participants for the following reasons: - Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN will be given as a single dose. - A comparator is not necessary for the evaluation of the objectives. - Blinding of the study treatment is not required as there is no comparator. - Conducting the study in healthy participants mitigates the potential confounding effects of the disease state and concomitant medications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05974046
Study type Interventional
Source Indivior Inc.
Contact
Status Completed
Phase Phase 1
Start date July 10, 2023
Completion date July 21, 2023
View Details
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