Safety
The incidence of any AEs observed in the carotegrast methyl alone group
was one out of 20 (5.0%), and
in the coadministration of carotegrast methyl with rifampicin group the
incidence was five out of 20 (25.0%). The incidence of AEs for which a
causal relationship with the study drug could not be ruled out was one
out of 20 (5.0%) in the carotegrast methyl alone group and one out of
20 (5.0%) in the rifampicin combination group. AEs in the
coadministration group with rifampicin for which a causal relationship
with concomitant drug could not be ruled out occurred in two out of 20
subjects (10.0%). The only AE in the carotegrast methyl alone group was
nausea (one of 20 subjects), while AEs in the coadministration group
with rifampicin were blood bilirubin increased (two of 20 subjects),
C-reactive protein increased (two of 20 subjects), and viral upper
respiratory tract infection (one of 20 subjects). All AEs were mild in
severity. AEs for which a causal relationship with the study drug could
not be ruled out were nausea in one out of 20 (5.0%) in the carotegrast
methyl alone group and viral upper respiratory tract infection in one
out of 20 (5.0%) in the rifampicin combination group. In the
coadministration group with rifampicin, the AE for which a causal
relationship with concomitant drugs could not be ruled out was blood
bilirubin increased, which occurred in two out of 20 subjects (10.0%).
Neither deaths nor the other SAEs were reported.