Safety, PK and PD of oral BGB324 in healthy male volunteers after SAD

• 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 Single Ascending Doses

• IRAS ID

  131641

• Contact name

  Lorch Ulrike

• Contact email

  u.lorch@richmondpharmacology.com

• Sponsor organisation

  BerGenBio AS

• Eudract number

  2013-001561-17

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  We are conducting a first time into human clinical research study of a new medicine called BGB324 which is being developed for slowing down or stopping the growth of cancerous tumours in the body. BGB324 is a chemical developed by BerGenBio AS (the sponsors of this study) that blocks the cellular activities of a specific type of receptor known as Axl kinase. Preclinical studies have shown BGB324 to be safe and effective.

  In this study we will test the safety and tolerability of BGB324 in healthy male volunteers as well as the pharmacokinetics (PK- how BGB324 is distributed and broken down in the body) and pharmacodynamics (PD- as we cannot assess the efficacy of BGB324 in treating cancer we will measure the activities of certain enzymes that are regulated by Axl RTK to see whether BGB324 has the expected effects). The data from the study will enable us to design future trials in healthy volunteers as well as cancer patients.
  Volunteers will receive one single oral dose of BG324 during the study and must be prepared to attend our clinical unit for 3 visits including 1 screening visit, 1 residential stay and 1 follow-up visits. The residential stay in our unit is over 6 days (5 nights) during which time, they will be administered the BGB324 on Day 1 of the study. Volunteers will be involved in the study for up to 41 days. The main procedures will include standard laboratory safety tests, vital signs, PK and PD sampling, physical examinations, 12-lead ECG, telemetry and monitoring of side effects. A pre-plug hair follicle sample may also be taken for PD analysis.

  The study has an adaptable design that allows the number of samples, number of volunteers and length of residential stay to be flexible within set limits.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/0698

• Date of REC Opinion

  12 Jun 2013

• REC opinion

  Further Information Favourable Opinion