Quantifying the analgesic potential of drugs in early-stage clinical trials
Centre of Human Drug ResearchVisit website
2333 CL Leiden
2333 CL Leiden
The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, is a clinical pharmacology research foundation that is involved in early phase clinical drug research. We perform clinical drug studies in collaboration with the pharmaceutical industry in many different areas, one of which is pain. On average 2-3 new analgesic compounds are tested in humans on a yearly basis. In the area of pain, CHDR is active in developing evoked pain tests that can be used in humans, and which allow the profiling of analgesic compounds in healthy subjects. Over the past decade, CHDR has developed a nociceptive test battery that can be applied in healthy human subjects, to quantify the analgesic potential of drugs on a range of mechanisms involved in clinical pain. This “PainCart” battery of tests has been extensively validated in healthy human subjects and in patients with pain and it has been used to demonstrate analgesic effects of a wide range of drugs.
CHDR will be responsible for the testing of the hypothesis generated by the in silico model, regarding the most effective combination of two analgesics, in healthy human subjects. Part of this strategy will be to share data from previous studies performed in healthy subjects and using the PainCart test battery will be used to establish the extended QPS model. In addition, CHDR will be responsible for the set-up of appropriate weights for different endpoints as predicted by the model, based on their clinical expertise in the field of chronic pain. Furthermore, CHDR will be responsible for performing two clinical trials to validate the 2 top drug combinations in healthy volunteers, based on pharmacokinetic parameters in plasma, clinical efficacy, and adverse effects of the top 2 drug combinations proposed by the QPS model, compared to placebo.