2. CLINICAL STUDY DESIGN AND PROTOCOL WRITING

Kinesis has extensive experience in the design of clinical trial protocols, especially phase I/IIa (hyperlink naar www.kinesis-pharma.com). Studies include first-enty-into-man studies in healthy subjects following a single rising dose and a multiple rising dose design, food-effect studies (fasting, standardized breakfast, high-fat meal etc.), formulation development studies (relative bioavailability), absolute bioavailability studies (comparison with IV administration) and bioequivalence studies with to-be-marketed-formulation (single and multiple dose) including bioequivalence statistics.

Another specialty of Kinesis is setting up protocols for C14 radiolabeled mass balance studies in healthy subjects. This includes calculation of the allowed radioactive dose based on preclinical studies (according to ARSAC guidelines).

There is much in-house experience on writing protocols for studies on drug-drug interactions. This includes single and multiple dose studies following parallel and cross-over designs for inhibitors and inducers of cytochrome P450 enzymes (e.g. ketoconazole, ritonavir), for narrow therapeutic index drugs (e.g. digoxin, warfarin), for co-administration with drugs that increase gastric pH (e.g. ranitidine, cimetidine, omeprazole). In some situations it may be needed to differentiate between poor and extensive metabolizers (e.g. by determining the dextrorphan / dextromethorphan ratio for CYP2D6)

Also protocols for studies in special populations (e.g. patients with impaired renal function, pediatric population) can be designed.

For Phase II and III studies sparse sampling strategies can be implemented to allow subsequent population PK analysis. See also our site about pharmacokinetic support.

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+31(0)76 54 80 666
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info@kinesis-pharma.com