ADME study of 14C-Acoziborole in healthy subjects (QSC202936)
Research type
Research Study
Full title
An Open Label, Single-dose, Single Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-Acoziborole
IRAS ID
273778
Contact name
Sharan Sidhu
Contact email
Sponsor organisation
Drugs for Neglected Diseases initiative
Eudract number
2019-004059-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 28 days
Research summary
The Sponsor is developing the test medicine, acoziborole, for the potential treatment of Human African Trypanosomiasis (HAT). HAT (also known as sleeping sickness) is spread to humans by the bite of infected tsetse files. In the first stage HAT can cause fever, headache, itchiness and joint pain. The second stage symptoms occur weeks to months later and include confusion, poor coordination, numbness and trouble sleeping and will eventually lead to death.
This study will try to track how the test medicine is taken up, broken down and removed from the body when given by mouth in the form of a capsule. The safety and tolerability of the test medicine will also be assessed.
The study will consist of one study period involving up to 6 healthy male volunteers. In this study, volunteers will receive a radiolabelled form of the test medicine, labelled with carbon-14. ‘Radiolabelled’ means that the test medicine has a radioactive component (carbon -14) which helps us to track how the test medicine is moving around the body. The volunteers will attend the clinic for a minimum of 12 days (Day-1 to Day 11). On Day 1, volunteers will receive a single dose of radio-labelled test medicine as four capsules.
Volunteers will be discharged 10 days after dosing and will have to return to the clinical unit for 5 separate return visits on Days 14-17, 28-31, 58-61, 88-91 and 118-121 after dosing for 48-hour collections of blood, faecal and urine samples. The total time volunteers will be involved in this study is expected to be approximately 22 weeks from the screening visit until the follow up phone call.
REC name
Wales REC 2
REC reference
20/WA/0002
Date of REC Opinion
17 Jan 2020
REC opinion
Favourable Opinion