This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
64
Single oral dose
Single oral dose
Research Site
Overland Park, Kansas, United States
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters.
Exploratory pharmacogenetic blood sampling.
Pharmacodynamic biomarker sampling; blood samples.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.