Extensive experience in pharmacokinetics studies
Profil has performed numerous dose-finding studies investigating the pharmacokinetics (PK) of new or modified drugs, in combination with and without pharmacodynamic profile assessments. We support our clients with advice on the appropriate study design and the potential dose range.
PK describes how the circulating concentration of a medicinal drug changes over time from administration until its elimination. Knowing the PK profile of a drug is important to determine treatment and understand its performance in terms of competitor medications.
It is also an important aspect of identifying potential toxic doses. While toxicity is determined in early preclinical trials, dose-finding studies aim to find the clinically relevant and tolerable dose. Such studies are usually designed as cohort studies that start with a very low dose, gradually increasing to the expected treatment dose and potentially going above it.
The drug-specific PK profile depends on several aspects: route of administration, absorption patterns, distribution in and metabolism by the body, elimination and/or degradation processes, and structural characteristics that potentially affect those processes. For example, insulin pharmacokinetics is highly dependent on specific structural changes (e.g., amino acid changes introduced to insulin analogues) and/or specific excipients such as absorption enhancers.
Pharmacokinetic trials could also answer specific scientific and mechanistic questions. For example, the effect of a drug, such as GLP-1 analogues, on gastric emptying could be determined by an absorption test with acetaminophen.
If you need a partner with world-leading experience in diabetes clinical trials and extensive knowledge about pharmacokinetics of insulin and others diabetes treatments, contact Profil Germany.