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

Phase 1

Completed

• Conditions: Heathy Volunteers
• Interventions: Drug: [14C]-acebilustat solution

• Registration Number: NCT03964558
• Lead Sponsor: Celtaxsys, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-04-14
• Study Completion: 2019-04-14
• Status Verified: 2019-05
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria

• Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
100 mg [14C]-acebilustat	[14C]-acebilustat solution	a single oral dose of 100 mg \[14C\]-acebilustat

Primary Outcome Measures

Name	Time	Method
Mass balance recovery of total radioactivity in all excreta: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the administered dose (Cum%Ae)	Day 10

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom