This is a 2-part, single-centre, randomised study in healthy males. Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males. Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
2-part, single-centre, randomised study in healthy males. Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males. Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Quotient Sciences
Nottingham, Mere Way Ruddington Fields Ruddington, United Kingdom
(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects
Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations
Time frame: up to 3days
(Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8356.
Time frame: up to 3days
(Part 1)]To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356- Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of SP-8356.
Time frame: up to 3days
(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Evaluate the effect of food on Maximum Observed Drug Concentration (Cmax) of SP-8356.
Time frame: up to 3days
(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Evaluate the effect of food on Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of SP-8356.
Time frame: up to 3days
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