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ADME Study of Acoziborole in Healthy Subjects

NCT04270981 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-04-27

No results posted yet for this study

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).

Conditions

  • Trypanosomiases, African

Interventions

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

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Sharan Sidhu, MBChB · Quotient Clinical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2020-07-08
Completion
2020-07-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270981 on ClinicalTrials.gov