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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
Single oral dose of 500 mg lucerastat under fasted conditions
Twice daily oral dose of 800 mg cimetidine under fasted conditions
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
Cmax of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
Tmax of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
AUC(0-t) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
AUC(0-inf) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
AUC(0-48) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
T1/2 of lucerastat
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Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Time frame: 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
Number of treatment-emergent AEs
Time frame: From Day 1 to End-of-Study (for up to 13 days)
Number of treatment-emergent SAEs
Time frame: From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days)