At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Lanraplenib.drug
Likely dose
Lanraplenib. 20 mgfrom 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.
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of GS-9876 in Subjects With Impaired Renal Function
In Brief
A Phase 1 clinical trial evaluating Lanraplenib. for Inflammatory Disease. Completed, enrolled 36 participants across 6 sites in 3 countries.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls. Participants in this study will be enrolled using an adaptive design that includes up to 3 enrolled cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in adaptive Cohorts 2 and/or 3.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Disease
CountriesGermany, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartNov 2016
Primary CompletionOct 2018
TodayJul 2026
First PostedNov 8, 2016
Enrollment StartNov 21, 2016
Primary CompletionOct 5, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.7 years ago
Interventions
Lanraplenib.drug
20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1