Table 1 Treatment-emergent adverse events with an incidence of > 1 in treatment groups after a single oral dose of JNJ-61803534, follow-up 42–57 days.
From: Preclinical and clinical characterization of the RORγt inhibitor JNJ-61803534
Placebo n = 12 | 10 mg n = 6 | 30 mg n = 6 | 100 mg (fasted) n = 9 | 100 mg (fed) n = 9 | 200 mg n = 6 | |
|---|---|---|---|---|---|---|
Diarrhea | 0 | 0 | 0 | 2 | 2 | 0 |
Aphthous ulcer | 0 | 0 | 0 | 0 | 1 | 1 |
Medical device site reaction | 1 | 0 | 1 | 2 | 2 | 1 |
Back pain | 0 | 1 | 0 | 1 | 1 | 1 |
Musculoskeletal discomfort | 0 | 0 | 0 | 0 | 0 | 2 |
Viral upper respiratory tract infection | 1 | 0 | 0 | 2 | 2 | 0 |
Oral herpes | 0 | 0 | 1 | 0 | 1 | 0 |
Headache | 2 | 0 | 1 | 4 | 0 | 0 |
Hypercholesterolaemia | 1 | 0 | 0 | 2 | 0 | 1 |
Nasal congestion | 0 | 0 | 0 | 2 | 0 | 0 |
