NCT03964558

Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)

An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Celtaxsys, Inc. · Academic / Other
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

Conditions

• Heathy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-acebilustat solution	Acebilustat is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-04-14
• Completion: 2019-04-14
• First posted: 2019-05-28
• Last updated: 2019-05-30

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study