Human ADME for YH12852 using wavelength scanning cavity ring-down spectroscopy (WS-CRDS) after a low radioactivity dose

Author:

Kim Anhye1ORCID,Dueker Stephen R2,Dong Feng3,Roffel Ad F4,Lee Sang-won56,Lee Howard7

Affiliation:

1. Department of Clinical Pharmacology & Therapeutics, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea

2. BioCore, Ltd, BioCore Co., Ltd, 9F, IT Mi-Rae Tower, #33 Digital-ro 9-gil, Geumcheon-gu, Seoul 08511, Republic of Korea

3. Picarro, Inc., 3105 Patrick Henry Drive, Santa Clara, CA 95954, USA

4. PRA Health Sciences, Van Swietenlaan 6, 9728 NZ Groningen, The Netherlands

5. Department of Clinical Pharmacology & Therapeutics, Seoul National University College of Medicine & Hospital, Seoul, Republic of Korea

6. Clinical Trial Center, Hanyang University Seoul Hospital, 222-1 Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea

7. Department of Transdisciplinary Studies, Graduate School of Convergence Science & Technology, Seoul National University, Seoul, Republic of Korea

Abstract

Aim: Human 14C radiotracer studies provide information-rich data sets that enable informed decision making in clinical drug development. These studies are supported by liquid scintillation counting after conventional-sized 14C doses (50–200 μCi) or complex accelerator mass spectrometry (AMS) after microtracer-sized doses (∼0.1–1 μCi). Mid-infrared laser-based ‘cavity ring-down spectroscopy’ (CRDS) is an emerging platform for the sensitive quantitation of 14C tracers. Results & methodology: We compared the total 14C concentrations in plasma and urine samples from a microtracer study using both CRDS and AMS technology. The data were evaluated using statistical and pharmacokinetic modeling. Conclusion: The CRDS method closely reproduced the AMS method for total 14C concentrations. With optimization of the automated sample interface and further testing, it promises to be an accessible, robust system for pivotal microtracer investigations

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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