This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Drug: APX-115 SAD APX-115 SAD for 1day
Drug: Placebo Placebo for 1day
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
Eurofins Optimed
Gières, France
SAD: incidence of treatment emergent adverse events
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram
Time frame: Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests
Time frame: Up to Day 8
MAD: incidence of treatment emergent adverse events
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from physical exams
Time frame: Up to Day 17
MAD: number of clinically significant abnormal findings from electrocardiogram
Time frame: Up to Day 17
Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Matching study drug will be repeatedly administered.
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
A metabolic probe will be administered with and without APX-115.
Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions
Time frame: Up to Day 4 post-dose
Food effect: ratio AUCfed/AUCfasted
Time frame: Up to Day 4 post-dose
Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: half-life (t1/2) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: clearance of a metabolic probe or APX-115
Time frame: Up to Day 4 post-dose
Drug interaction: Incidences of treatment emergent adverse events
Time frame: Up to Day 4 post-dose
SAD: time to reach Cmax (Tmax) of APX-115
Time frame: Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115
Time frame: Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)
Time frame: Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115
Time frame: Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115
Time frame: Up to Day 5
SAD: clearance (CL/F) of APX-115
Time frame: Up to Day 5
MAD: peak serum concentration (Cmax) of APX-115
Time frame: Up to Day 11
MAD: time to reach the Cmax (Tmax) of APX-115
Time frame: Up to Day 11
MAD: Area Under the Curve (AUC) of APX-115
Time frame: Up to Day 11
MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)
Time frame: Up to Day 11
MAD: volume of distribution (Vd/F) of APX-115
Time frame: Up to Day 11
MAD: Clearance (CL/F) of APX-115
Time frame: Up to Day 11
MAD: accumulation ratio
Time frame: Up to Day 11
Food effect & drug interaction: incidence of treatment emergent adverse events
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from physical exam
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from electrocardiogram
Time frame: Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from biological tests
Time frame: Up to Day 4 post-dose