drugset / Trial / NCT02626026
Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2016-01-26
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirabrutinib | Small molecule | 10 mg | Oral |
| Subject | Tirabrutinib | Small molecule | 20 mg | Oral |