A 3-part Study to Assess Safety, Tolerability, PK and PD of Single (Part 1) and Multiple (Part 2) Ascending Doses of EXS21546, and to Evaluate the Relative Bioavailability of a Solid Dose Formulation Compared to a Powder for Oral Suspension (Part 3), in Healthy Male Subjects.
Part 1 is a randomised, double-blind, placebo-controlled, SAD study with a food effect assessment. Part 2 is a randomised, double-blind, placebo controlled, MAD study over 14 days. In order to explore the potential CYP3A4 inducer effect, midazolam will also be administered in one cohort. Part 3 is a 3-period, open label, randomised, sequential study. Each subject will receive solid dose formulation and powder for oral suspension in a randomised manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Quotient Sciences
Nottingham, United Kingdom
Number of participants with treatment emergent Adverse Events
Number of participants with treatment emergent Adverse Events
Time frame: 1 month
EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)
EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)
Time frame: 17 days
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
Time frame: 17 days
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Fed/Fasted
Placebo Powder for Oral Suspension