Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: yes

Brief summary:
This study will consist of two parts: Part A will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of tirabrutinib in healthy participants. Part B will evaluate the safety, tolerability, and the effect of tirabrutinib on disease-specific clinical markers and outcomes in participants with rheumatoid arthritis (RA).

Detailed description:

Arms:
arm 1: Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week. arm 2: Placebo to match tirabrutinib capsules orally QD in the morning for 1 week. arm 3: Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered. arm 4: Placebo to match tirabrutinib capsules orally BID (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered. arm 5: Tirabrutinib 20 mg capsules orally QD for 4 weeks. arm 6: Placebo to match tirabrutinib capsules orally QD for 4 weeks.

Interventions: intervention 1: Tirabrutinib intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules administered orally. intervention 2: Capsules administered orally.

Protocol document: