drugset / Trial / NCT02626026

Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)

NCT02626026

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

EvaluationDrugModalityDoseRoute
Subject Tirabrutinib Small molecule 10 mg Oral
Subject Tirabrutinib Small molecule 20 mg Oral

Indications