NCT04270981

ADME Study of Acoziborole in Healthy Subjects

An Open Label, Single-dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-Acoziborole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single centre, open-label, single group, non-randomised, single oral dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification, and exploratory pharmacodynamics of acoziborole. It is planned to enrol 6 subjects. All subjects will receive an oral dose of 960 mg \[14C\] acoziborole on a single occasion as 4 capsules containing a small amount of radioactivity (not more than \[NMT\] 1000 nCi \[37 KBq\] 14C).

Detailed description

The present study aims to further understand and quantify the absorption, distribution, metabolism and elimination (ADME) of acoziborole in humans through the assessment of the mass balance recovery after a single oral dose of \[14C\]-acoziborole. The routes and rates of elimination of \[14C\]-acoziborole will be determined and plasma, urine and faecal samples will be used for metabolic profiling and structural identification. Subjects will be screened for inclusion in the study up to 28 days before dosing. Subjects will be admitted in the evening on the day before dosing (Day 1). Subjects will be dosed on the morning of Day 1 following an overnight fast of a minimum of 9 h, and will remain resident in the clinic until up to 240 h after dosing (up to Day 11). Subjects will return to the clinical unit for 5 additional 48 h collection periods, admitting to the clinical unit the evening before the collection period. The additional collection periods will be on Days 14 to 17, 28 to 31, 58 to 61, 88 to 91 and 118 to 121. A follow up call will take place 5 to 10 days post-final discharge to ensure the ongoing wellbeing of subjects.

Conditions

• Trypanosomiases, African

Interventions

Type	Name	Description
DRUG	[14C]-acoziborole capsule, 240 mg containing NMT 9.25 kBq (250 nCi) 14C	960 mg (4 × 240 mg capsules)of acoziborole in oral and fasted condition

Timeline

• Start date: 2020-02-05
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2020-02-17
• Last updated: 2021-04-27

Locations

1 site across 1 country: United Kingdom