Dept. of Clinical… KliPS KliPS-Leistungsbereich…

Special Phase I clinical trials

Scope

  • In-depth expertise with > 35 trials performed on kinetic aspects of drug development (drug-drug interaction, drug-food interaction, bioequivalence trials).
  • Genetic features of metabolism: a biobank allows the inclusion of participants with genetic variants of metabolism of different liver enzymes or transporters.
  • In-depth expertise with > 30 trials performed on pharmacodynamic aspects of drug development (endogenous biomarkers, QTc trials, cardiovascular safety, pain measurement).
  • Innovative analytical methods allow the evaluation of liver enzyme activity with microdosing of relevant marker substances (e.g., micro-midazolam for evaluation of CYP3A4 activity).
  • Intra-clinical and intra-campus cooperation: evaluation of target organs (e.g. echocardiography, cardio-MRI, fibroscan of the liver, liver biopsy, bone marrow puncture) and extensive laboratory parameters (e.g. cytokines).

Mission

Special Phase I studies require special experience and special capabilities

Background

The phase I development of a drug needs additional trials besides the first-in-human trial to evaluate pharmacokinetics and dynamics in detail to increase drug safety.



Most visited


EN