Safety, PK and PD of multiple oral BGB324 in healthy male volunteers
Research type
Research Study
Full title
A Phase I, Single Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral BGB324 in Healthy Male Volunteers After Multiple Doses
IRAS ID
137896
Contact name
Lorch Ulrike
Contact email
Sponsor organisation
BerGenBio AS
Eudract number
2013-003089-15
ISRCTN Number
non provided
Research summary
This study is a clinical trial of a new medicine called BGB324 which is being developed by BerGenBio AS (the sponsors of the study) for slowing down or stopping the growth of cancerous tumours in the body. We are currently conducting a single ascending dose study with BGB324 which is the first time BGB324 has been given to humans. The data from the single dose study, so far shows that BGB324 is safe and well tolerated. Hence in this new study we will test the safety, tolerability, pharmacokinetics (PK - how BGB324 is distributed and broken down in the body) and pharmacodynamics (PD - refer to section A6.2 below) when BGB324 is given as multiple doses.
It is anticipated that volunteers will receive BGB324 using 1 of 2 dosing regimes i.e. either 4 or 6 doses given over 2 weeks so we can determine the most effective dosing regimen to give to cancer patients. Volunteers will be involved in the study for up to 60 days including the time when we determine who is suitable for taking part in the study, conduct of the study and the follow-up, 14 days after discharge from the unit.
The main procedures will include standard laboratory safety tests (haematology, clinical chemistry, coagulation and urinalysis), vital signs (temperature, blood pressure and pulse), physical examinations, 12-lead ECG, 24 hour Holter, telemetry, PK and PD blood and urine samples and monitoring of side effects. A pre-plug hair follicle sample may also be taken for PD analysis.
Volunteers will not receive any benefits from taking BGB324 as it is being given for research and development purposes but they will be compensated for their time.
The study has an adaptable design that allows the dosing regimen, number of samples and assessments, and length of residential stay to be flexible within set limits.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1133
Date of REC Opinion
28 Aug 2013
REC opinion
Favourable Opinion