A unique set of approaches to learn about the pharmacokinetics and metabolism of your asset.
Overview
Studies with 14C-labelled small molecule investigational medicinal products (IMPs) in humans have long served to help elucidate the absorption, metabolism and excretion (AME) of such IMPs and continue to play an important role in early clinical drug development and learning about your drug. At the same time, these studies come with complexities that differ from other human pharmacology studies, such as the need to synthesize radiolabelled drug substance, run human dosimetry calculations (if not exempted), manufacture the radiolabelled IMP, design and run the clinical study, and assess excretion and metabolite formation.
Absolute bioavailability (ABA) studies using an intravenous, 13C- or 14C-labelled microdose are now accepted as the most attractive, efficient approach to assess this important parameter in humans, without the need for intravenous toxicology studies.
During this webinar we shared our vast experience and insights on human AME and intravenous microdose ABA studies, based on more than 120 studies with radioisotope-labelled drugs that we have conducted during the past 12 years.
Topics included:
- Various approaches and considerations on AME and ABA studies with radiolabelled material in humans have been published. This webinar will integrate these and provide a concise overview that will be informative to those who are interested in understanding how designs and technologies may be tailored to their development.
- The various unique aspects of running a study in humans using 14C-labelled compound, including on-site manufacturing and quality control of your Investigational Medicinal Products (IMPs).
- The factors driving the decision to run your human AME study with a traditional or a microtracer dose of 14C.
- The design and advantages of ABA studies in humans using an intravenous, 13C- or 14C-labelled microdose.
- What drives the decision to run your AME or ABA study in healthy volunteers or in cancer patients and how we can support you in that patient population.
- How this approach fits within the expectations of regulators and guidelines.
The webinar was hosted by the ASCPT. Please follow the link below to watch the recording.
Speakers
Ad is a Senior Director of Clinical Pharmacology at 91黑料. He is involved in advising and supporting our customers with respect to drug development, including the design of studies, PK and PD parameters, inclusion/exclusion criteria, and ethics. Focus areas have been thorough QT studies, respiratory medicine, and 14C microdosing and AME studies.
Arjen Akkerman
Arjen is Senior Director CMC and Qualified Person at 91黑料. He is responsible for running and maintaining a GMP?compliant manufacturing facility for IMPs. His field of expertise are oral and parenteral formulations including radiolabelled IMPs for use in early phase clinical trials and microdose/microtracer formulations.
Target Audience
This webinar will help all who are involved in human AME and ABA studies, and studies with 14C-labelled tracer compounds to understand the complexities and start finding solutions to run these early phase clinical studies, especially Clinical Study Leaders, Clinical Pharmacologists, and Pharmacokineticists.
Although not the main topic of the presentation, concepts applied in human AME studies are very well applicable to further translational medicine questions, for example on proof-of-mechanism for novel agents affecting an endogenous metabolic pathway for which a tracer compound can be used. 91黑料 will be delighted to discuss this further for your novel compound.