Katholieke Universiteit Leuven
Katholieke Universiteit Leuven / Catholic University Leuven
Oude Markt 13
Clinical Pharmacology, General Internal Medicine
Expertise: Early clinical drug development and clinical trial methodology
Phone: +32 16 3420 20
Fax: +32 16 3420 50
Prof. Dr. Jan de Hoon, MD, PhD, MSc
Jan de Hoon initially obtained a Master’s degree in Chemical Sciences and was then trained as a physician. He has over 15 years of experience and a longstanding track record in conducting Phase I and II clinical studies, partly in industry and partly in academia.
The LENA Team in Leuven
At the Katholieke Universiteit Leuven, maintaining superior quality of the research output by full implementation of Standard Operating Procedures and delivering results on time are given top priority.
The study with healthy adults will be conducted at the Center for Clinical Pharmacology (CCP) an Academic Research Organization (ARO) at the University Hospitals of Leuven under the supervision of Prof. Jan de Hoon as Principal Investigator. In accordance with its academic assignment, the Center for Clinical Pharmacology has three core tasks:
- perform contract research in collaboration with industrial Partners
- conduct scientific research in clinical pharmacology
- be actively involved in teaching basic and clinical pharmacology at an undergraduate, graduate and post- graduate level.
The Centre for Clinical Pharmacology is located within the University Hospitals of Leuven, Belgium, the largest university hospital in Europe, and offers a professional environment for conducting phase I and early phase II clinical trials according to ICH/GCP guidelines. Thirty beds are currently available for overnight stay to perform early and exploratory clinical drug development studies in accordance with the highest safety, quality and ethical requirements. State-of-the-art GMP facilities are available for the storage and production of investigation medicinal products; the unit is GMP certified since April 2013.
The following types of studies in the exploratory phase of clinical drug development are performed at the CCP:
- First-in-man studies (FIM) including single and multiple ascending dose
- Exploratory clinical trials (eCTAs), including microdosing studies
- Proof-of-Principle/Proof-of-Concept studies (PoP/PoC)
- Early patient exposure and imaging studies using Positron Emission
- Tomography (PET) with a focus on CNS penetration and receptor occupancy.
A permanent staff of over 15 people (including clinical study nurses, laboratory staff and trial management staff) is employed at the CCP, while a pool of on call assistant clinical study nurses is available to assist with the execution of clinical trials. A database with over 7.000 potential healthy volunteer candidates, blood sampling and storage facilities, laboratories, clinical investigation and recreation rooms, medication storage facilities are currently available to perform bioavailability and early clinical drug development studies in accordance with the highest safety, quality and ethical requirements. All necessary infrastructure and equipment is thus available for the completion of the bioavailability study involving 24 healthy volunteers.