NCT05974046

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	[14C]IDV184001AN	\[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension

Timeline

• Start date: 2023-07-10
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2023-08-03
• Last updated: 2025-02-13
• Results posted: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study