Procedures
liver injury
EVENTS, BLIND
All patients received 5 film-coated tablets daily to be taken orally before breakfast, supplied as placebo or BI 1467335 in 1 mg and 5 mg dose strengths. Each treatment group received a combination of placebo and BI 1467335 tablets corresponding to the appropriate dose (e.g. the 6 mg dose group received 1 × 5 mg BI 1467335, 1 × 1 mg BI 1467335, 3 × placebo). All treatments were double blind. Assessments of sAOC3 activity and concentration, ALT, AST, AP, GGT, CK-18 caspase and CK-18 total, and other exploratory biomarkers were carried out at each study visit. Study visits took place every 2 weeks for the first 8 weeks, at Week 12 and at a follow-up visit 4 weeks after trial drug termination (Week 16). TEAEs were recorded at each study visit, at follow-up and by telephone call on Days 27 and 83. TEAESIs were liver injury events (ALT and/or AST 5–8 × baseline or >300 U/L in patients with ALT and/or AST > ULN at baseline; AST 3–8 × ULN in patients with normal AST at baseline) and trial-specific procedures for the removal of individual patients were defined in cases of increased liver enzymes (AST, ALT and total bilirubin) after randomisations