CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Tirabrutinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02626026
NCT02626026Phase 1Completed
CompareCT.gov

A Phase 1, Placebo-Controlled, Randomized Study Evaluating the Safety and Pharmacokinetics of GS-4059 in Healthy Volunteers and Subjects With Rheumatoid Arthritis (RA)

Gilead Sciences·interventional·Posted Dec 10, 2015·Updated Sep 9, 2020

In Brief

A Phase 1 clinical trial evaluating Tirabrutinib and Placebo for Rheumatoid Arthritis. Completed, enrolled 42 participants across 9 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 10, 2015
Enrollment StartJan 26, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.6 years ago

Interventions

Tirabrutinibdrug

Capsules administered orally.

Placebodrug

Capsules administered orally.