Microtracer
Insight into intravenous pharmacokinetic (IVPK) and absolute bioavailability can be provided at the earliest opportunity by incorporating an ivMicrotracerTM dose into a First-in-Human study. In such a protocol, one of the ascending dose increments is expanded to include a carbon-14 labelled iv Microtracer, which is administered when the oral unlabelled drug has reached Cmax. Analysis of 14C labelled compound provides IVPK data and, when compared to the unlabelled oral pharmacokinetic data, delivers an absolute bioavailability read out.
The early insight that such an approach provides allows early human metabolism to be considered when planning the future development of the drug.
For more information download the ivMicrotracer and FIH factsheets.