BI 1467335 in healthy volunteers using PET-CT.
Research type
Research Study
Full title
A Phase I, open-label, Positron Emission Tomography study in healthy male subjects to explore the inhibition of monoamine oxidase B in the brain after multiple oral doses of BI 1467335 (non-randomized, open-label, parallel-group study).
IRAS ID
255674
Contact name
Chris Woods
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2018-003745-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 27 days
Research summary
This is a study in healthy, non-smoking men aged 21-55 years, to test the effects of different doses of BI 1467335 on MAO-B activity in the brain. MAO-B is a protein that affects levels of substances which control the transmission of nerve signals. BI 1467335 will be given as a tablet formulation of dose strengths 5 mg and 1 mg. Dose group 1 will be given 10 mg (2 x 5 mg) once daily for twenty-eight days. Dose group 2 will be given 3 mg of (3 x 1 mg) once daily for forty-two days. All subjects will be required to stay in the clinical unit for the duration of the study. Each subject will undergo combination Positron Emission Tomography (PET) and Computerised Tomography (CT) scans, known as PET-CT, at 3 time points throughout the study (1 before and 2 after first dose). A PET scan is an imaging technique which can provide 3-dimensional images by detecting radiation given off by a molecule injected into the body, called a “radiotracer” or “ligand”. A CT scan uses x-rays to produce further detail and is used with PET scans to produce accurate data. Subjects will also be required to give blood for safety analysis, biomarker analysis (a naturally-occurring molecule in the body which indicates the status of a condition), pharmacokinetic analysis (how the study drug is utilised within the body) and pharmacogenetic analysis (looking at DNA). Subjects will also undergo several ECGs (to record the heart’s electrical activity) and vital signs (such as blood pressure and heart rate) monitoring along with urine sampling and physical examinations. A single Magnetic Resonance Imaging [(MRI) -imaging technique using magnets to form detailed pictures of the body] will also be performed per subject. Subjects will attend a separate facility for the imaging scans.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0070
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion