Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 1 Part 2 Part 2 Part 2 Part 2
System Organ Class PlaceboLSF / IRT N=16 n (%) 0.1 mg LSF N=1 n (%)a 1 mg LSF N=5 n (%) 2.5 mg LSF N=6 n (%) 5 mg LSF N=6 n (%) 5 mg IRT N=5 n (%) 10 mg LSF N=6 n (%) 20 mg LSF N=6 n (%) 20 mg IRT N=6 n (%) 40 mg LSF N=6 n (%) All subjects N=63 n (%) Placebo LSF / IRT N=4 n (%) 10 mg LSF (fed) N=6 n (%) 40 mg LSF (fasting) N=6 n (%) All subjects N=16 n (%)
Any TEAE 6 (37.5) 1 (100) 3 (60.0) 0 3 (50.0) 3 (60.0) 5 (83.3) 3 (50.0) 2 (33.3) 5 (83.3) 31 (49.2) 0 3 (50.0) 5 (83.3) 8 (50.0)
Nervous system disorders 2 (12.5) 0 2 (40.0) 0 1 (16.7) 1 (20.0) 1 (16.7) 1 (16.7) 1 (16.7) 3 (50.0) 12 (19.0) 0 2 (33.3) 4 (66.7) 6 (37.5)
Eye disorders 1 (6.2) 0 0 0 0 1 (20.0) 2 (33.3) 1 (16.7) 0 5 (83.3) 10 (15.9) 0 0 5 (83.3) 5 (31.3)
Infections & infestations 0 1 (100) 0 0 1 (16.7) 0 1 (16.7) 1 (16.7) 0 1 (16.7) 5 (7.9) 0 0 0 0
Musculoskeletal and connective tissue disorders 0 0 1 (20.0) 0 1 (16.7) 1 (20.0) 0 0 1 (16.7) 1 (16.7) 5 (7.9) 0 0 1 (16.7) 1 (6.3)
Respiratory, thoracic and mediastinal disorders 1 (6.2) 0 0 0 0 0 1 (16.7) 1 (16.7) 1 (16.7) 0 4 (6.3) 0 1 (16.7) 1 (16.7) 2 (12.5)
Gastrointestinal disorders 2 (12.5) 0 0 0 1 (16.7) 0 0 0 1 (16.7) 0 4 (6.3) 0 0 3 (50.0) 3 (18.8)
General disorders and administration site disorders 0 0 0 0 2 (33.3) 0 0 0 0 0 2 (3.2) 0 0 3 (50.0) 3 (18.8)
Injury, poisoning and procedural complications 1 (6.2) 0 0 0 0 0 0 1 (16.7) 0 0 2 (3.2) 0 0 0 0
Psychiatric disorders 0 0 0 0 0 1 (20.0) 0 0 0 0 1 (1.6) 0 0 1 (16.7) 1 (6.3)