The present study is designed to assess the safety and tolerability of escalating, multiple ascending doses of Cavosonstat (N91115) in healthy subjects.
Name: Cavosonstat
Name: Placebo
Description: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 14 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine.
Measure: Pharmacokinetic parameters of N91115 and metabolites (Amount of analyte excreted in the urine [Ae]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine.
Measure: Pharmacokinetic parameters of N91115 and metabolites (% analyte excreted in the urine [Fe]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (area under the curve [AUC]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (maximum concentration [Cmax]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in urine and plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (clearance [CL]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (accumulation index [Racc]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (Terminal elimination half-life [t1/2]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (time of maximum concentration [Tmax]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (metabolite to parent exposure ratio [M/P ratio]) Time: 7 daysDescription: Pharmacokinetic parameter of N91115 and metabolites will be measured in plasma.
Measure: Pharmacokinetic parameters of N91115 and metabolites (terminal elimination rate constant [lambda z]) Time: 7 daysAllocation: Randomized
Parallel Assignment
There is one SNP
Eligible subjects will be randomized in a 3:1 ratio to receive investigational medicinal product (IMP) N91115 (daily [QD] or every 12 hours [Q12H]) or matching placebo (QD or Q12H) for 7 days and will be followed for safety while housed in the clinical research unit (CRU) until discharge on Day 8. Pharmacokinetics will be followed from Study Day 1 through the morning of Study Day 8. --- Q12H ---
Eligible subjects will be randomized in a 3:1 ratio to receive investigational medicinal product (IMP) N91115 (daily [QD] or every 12 hours [Q12H]) or matching placebo (QD or Q12H) for 7 days and will be followed for safety while housed in the clinical research unit (CRU) until discharge on Day 8. Pharmacokinetics will be followed from Study Day 1 through the morning of Study Day 8. --- Q12H --- --- Q12H ---