Phase 1 Study
The Phase 1 study of dutogliptin evaluated safety, pharmacokinetics and pharmacodynamics in healthy volunteers after single and repeated parenteral application.
Status of Study
Enrolment completed in September 2017 at the University Hospital of Vienna, Austria.
Study Rationale and Design
While dutogliptin has an excellent and well-known safety profile because it was initially developed to treat diabetes, this study evaluated a new form of administration. Specifically, healthy volunteers received single and repeated parenteral applications to understand dutogliptin’s safety, pharmacokinetics and pharmacodynamics. To that end, the study was designed with nine cohorts as an open-label, single center study.
The study confirmed the acceptable safety and tolerability profile of dutogliptin with volunteers reporting only mild to moderate discomfort primarily related to the actual injections. The study also established the dosage and the dosing schedule for a future clinical study.