*An Open-Label Mass Balance Study of [14C]-pelabresib in Healthy Male Subjects
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]-pelabresib in Healthy Male Subjects
IRAS ID
1006147
Contact name
Tanja Ligensa
Contact email
Sponsor organisation
Constellation Pharmaceuticals Inc.
ISRCTN Number
ISRCTN10750305
Research summary
The Sponsor is developing the test medicine, pelabresib, for the potential treatment of myelofibrosis, a type of blood cancer, and other blood disorders. Blood cancers affect the production and function of blood cells meaning too many or too few blood cells may be produced. This one-part healthy volunteer study will try to identify how the test medicine is taken up and broken down by the body when given by the mouth in the form of radioactive suspension. The test medicine is ‘radiolabelled’ meaning the test medicine has a radioactive component (Carbon-14) to help track where the medicine is in the body. This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 30-65 years. The volunteers will receive a single radiolabelled oral dose of 10 mg suspension in a fasted state. Volunteers will be discharged on Day 19 and will receive a follow up phone call on 3-10 days post discharge. After dosing, all urine and faeces passed by the volunteers will be collected until Day 19. Blood samples will also be collected during the study. Volunteers are expected to be involved in this study for approximately 8 weeks from screening to the discharge.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0610
Date of REC Opinion
9 Nov 2022
REC opinion
Further Information Favourable Opinion