Safety
The incidence of any AEs when carotegrast methyl was combined with
orally administered midazolam, prednisolone, atorvastatin, and
intravenously administered midazolam, and for carotegrast methyl alone
was 17/20 (85%), 5/20 (25%), 1/20 (5%), 16/20 (80%), 2/8 (25%),
respectively. All AEs were mild in severity except for moderate upper
limb fracture in combination with prednisolone and moderate influenza in
combination with atorvastatin, all of which resolved except upper limb
fracture. The most common AE was somnolence, which was reported in 17/20
(85%) of subjects receiving a concomitant oral midazolam and 15/20
(75%) of subjects receiving concomitant intravenous midazolam. AEs
leading to discontinuation of the study were 1/20 (5%) in the
combination with prednisolone and 1/20 (5%) in the combination with
atorvastatin. Neither deaths nor the other serious AEs were reported.