A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
Randomised, double-blind Phase I study (n=60) evaluating single oral doses of KUR-101 versus placebo and oxycodone in healthy adults to assess safety, PK/PD, analgesic and respiratory effects.
Details
This single-centre Phase I study in healthy adults is conducted in two parts: Part 1 is a randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate safety, tolerability, PK and PD of orally administered KUR-101; Part 2 is a randomized, double-blind, three-period crossover comparing KUR-101, placebo and OxyNorm to assess analgesic and respiratory effects.
Part 1 enrols cohorts of 8 (5 cohorts) randomised to active or placebo with one cohort returning for a food-effect assessment; Part 2 enrols participants in a three-way crossover with 7-day washouts between single-dose periods. Outcomes include safety, adverse events, PK parameters, analgesic and respiratory measures.