A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects

Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)

Cmax was used to assess dose proportionality across all dose groups

Time frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose

Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)

AUC from time zero to infinity \[AUC(0-inf)\] was used to assess dose proportionality across all dose groups

Time frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7

Terminal elimination half-life (t1/2)

t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses

Time frame: PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7

Food effect on lucerastat pharmacokinetics assessed by Cmax

Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing Cmax in fed vs fasted state in the 500 mg cohort (cohort 2)

Time frame: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose

Food effect on lucerastat pharmacokinetics assessed by AUC

Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing AUC in fed versus fasted state in the 500 mg cohort (cohort 2)

Time frame: PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose

Number of participants with adverse events (AEs)

An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment