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ADME Study of Acoziborole in Healthy Subjects

ADME Study of Acoziborole in Healthy Subjects

Recruiting
18-55 years
Male
Phase 1

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.

Study details
    African Trypanosomiasis

NCT04270981

Drugs for Neglected Diseases

19 February 2024

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