Trial Outcomes & Findings for Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function (NCT NCT02959138)

Last Updated: 2019-10-25

Results Overview

AUClast is defined as the concentration of drug from time zero to the last observable concentration. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1

Results posted on

2019-10-25

Participant Flow

Participants were enrolled at study sites in United States, New Zealand, and Germany. The first participant was screened on 21 November 2016. The last study visit occurred on 05 October 2018.

75 participants were screened. Participants in adaptive Cohort 3 (Mild renal impairment) were not enrolled following review of safety and pharmacokinetic (PK) data from participants in Cohort 1 (moderate renal impairment).

Participant milestones

Participant milestones
Measure	Moderate Renal Impairment Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Severe Renal Impairment Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Healthy Control Matched healthy control participants received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
Overall Study STARTED	10	10	16
Overall Study COMPLETED	10	9	16
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Moderate Renal Impairment Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Severe Renal Impairment Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Healthy Control Matched healthy control participants received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
Overall Study Enrolled but Never Treated	0	1	0

Baseline Characteristics

Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moderate Renal Impairment n=10 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Severe Renal Impairment n=9 Participants Participants with severe renal impairment received a single oral dose of 20 mg (2 x 10 mg tablets) lanraplenib tablets in a fasted state, on Day 1.	Healthy Control n=16 Participants Matched healthy control participants received a single oral dose of 20 mg (2 x 10 mg tablets) lanraplenib tablets in a fasted state, on Day 1.	Total n=35 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 5.5 • n=5 Participants	59 years STANDARD_DEVIATION 11.6 • n=7 Participants	61 years STANDARD_DEVIATION 9.4 • n=5 Participants	62 years STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	9 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment New Zealand	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	8 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Estimated Creatinine Clearance (CLcr)	45.3 mL/min STANDARD_DEVIATION 11.46 • n=5 Participants	23.4 mL/min STANDARD_DEVIATION 4.31 • n=7 Participants	104.0 mL/min STANDARD_DEVIATION 16.21 • n=5 Participants	66.5 mL/min STANDARD_DEVIATION 37.96 • n=4 Participants

PRIMARY outcome

Timeframe: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1

Population: PK Analysis Set included all enrolled participants who took study drug, had at least 1 nonmissing postdose concentration value reported by PK lab for corresponding analytes, based on CLcr. Some healthy control participants matched to participants with moderate renal impairment were also used as matches to participants with severe renal impairment.

Outcome measures

Outcome measures
Measure	Cohort 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 1: Healthy Control n=8 Participants Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Severe Renal Impairment n=9 Participants Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Healthy Control n=9 Participants Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr	2317.8 h*ng/mL Standard Deviation 813.83	2027.4 h*ng/mL Standard Deviation 424.52	2076.3 h*ng/mL Standard Deviation 812.99	1871.6 h*ng/mL Standard Deviation 519.06

PRIMARY outcome

Timeframe: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1

Population: Participants in the PK Analysis Set were analyzed, based on CLcr. Some healthy control participants matched to participants with moderate renal impairment were also used as matches to participants with severe renal impairment.

AUCinf is defined as the concentration of drug extrapolated to infinite time. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min

Outcome measures

Outcome measures
Measure	Cohort 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 1: Healthy Control n=8 Participants Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Severe Renal Impairment n=9 Participants Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Healthy Control n=9 Participants Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
PK Parameter: AUCinf of Lanraplenib Presented Based on Range of CLcr	2478.7 h*ng/mL Standard Deviation 908.61	2153.0 h*ng/mL Standard Deviation 435.44	2223.4 h*ng/mL Standard Deviation 855.97	1994.2 h*ng/mL Standard Deviation 528.55

PRIMARY outcome

Timeframe: 0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1

Cmax is defined as the maximum concentration of drug. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min

Outcome measures

Outcome measures
Measure	Cohort 1: Moderate Renal Impairment n=8 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 1: Healthy Control n=8 Participants Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Severe Renal Impairment n=9 Participants Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Healthy Control n=9 Participants Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
PK Parameter: Cmax of Lanraplenib Presented Based on Range of CLcr	134.4 ng/mL Standard Deviation 35.47	131.6 ng/mL Standard Deviation 33.71	118.0 ng/mL Standard Deviation 38.97	130.5 ng/mL Standard Deviation 30.77

SECONDARY outcome

Timeframe: Day 1 up to Day 31

Population: The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.

Outcome measures

Outcome measures
Measure	Cohort 1: Moderate Renal Impairment n=10 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 1: Healthy Control n=9 Participants Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Severe Renal Impairment n=16 Participants Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Healthy Control Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events	60.0 percentage of participants	55.6 percentage of participants	12.5 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 up to Day 31

Population: Participants in the Safety Analysis Set were analyzed. Grouping for the analysis was done based on CLcr.

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. The criteria used for grading was Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.

Outcome measures

Outcome measures
Measure	Cohort 1: Moderate Renal Impairment n=10 Participants Participants with moderate renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 1: Healthy Control n=9 Participants Matched healthy control participants to moderate renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Severe Renal Impairment n=16 Participants Participants with severe renal impairment received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.	Cohort 2: Healthy Control Matched healthy control participants to severe renal impairment cohort, received a single oral dose of lanraplenib 20 mg (2 x 10 mg tablets) in a fasted state, on Day 1.
Percentage of Participants Who Experienced Graded Laboratory Abnormalities Any Graded Laboratory Abnormality	80.0 percentage of participants	100.0 percentage of participants	81.3 percentage of participants	—
Percentage of Participants Who Experienced Graded Laboratory Abnormalities Grade 3 or above Laboratory Abnormalities	30.0 percentage of participants	44.4 percentage of participants	0 percentage of participants	—

Adverse Events

Moderate Renal Impairment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Severe Renal Impairment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER

Measure	Moderate Renal Impairment n=10 participants at risk Participants with moderate renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.	Severe Renal Impairment n=9 participants at risk Participants with severe renal impairment received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.	Healthy Control n=16 participants at risk Matched healthy control participants received a single oral dose of 20 mg lanraplenib tablets in a fasted state, on Day 1.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Constipation	10.0% 1/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Melaena	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Nausea	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
General disorders Fatigue	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
General disorders Thirst	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Metabolism and nutrition disorders Hypokalaemia	10.0% 1/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	6.2% 1/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Nervous system disorders Dizziness	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Nervous system disorders Headache	20.0% 2/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	12.5% 2/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Renal and urinary disorders Proteinuria	0.00% 0/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	11.1% 1/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.
Skin and subcutaneous tissue disorders Urticaria	10.0% 1/10 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/9 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.	0.00% 0/16 • Day 1 up to Day 31 The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.