Healthy Subjects
Conditions
Brief summary
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.
Interventions
DRUGLucerastat
Single oral dose of 500 mg lucerastat under fasted conditions
DRUGCimetidine
Twice daily oral dose of 800 mg cimetidine under fasted conditions
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Fixed sequence
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in the local language prior to any study-mandated procedure. * Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening. * Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.
Exclusion criteria
* Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed). * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
| Tmax of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
| AUC(0-t) of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
| AUC(0-inf) of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
| AUC(0-48) of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
| T1/2 of lucerastat | Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days | Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment-emergent AEs | From Day 1 to End-of-Study (for up to 13 days) |
| Number of treatment-emergent SAEs | From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days) |
Countries
Germany
Outcome results
None listed