Inflammatory DiseasePhase 1NCT02959138

Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function

A Phase 1 study testing Lanraplenib. in people with Inflammatory Disease, run by Gilead Sciences at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Inflammatory Disease
What is being tested?: Lanraplenib.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 6 sitesin 3 countries
Study dates: 21 Nov 2016to 5 Oct 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Individuals
Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures
Have a calculated body mass index (BMI) of ≥ 18 kg/m^2 and ≤ 36 kg/m^2 at screening
Females of childbearing potential must have a negative pregnancy test at screening and clinic admission (Day -1).
Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the sponsor

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Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
For Individuals with Renal Impairment
Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant change in renal function status within 90 days prior to study drug administration (Day 1).
Have a creatinine clearance (CLcr) < 90 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening.
For Healthy Matched Controlled Individuals (Individuals with Normal Renal Function)
Have a CLcr ≥ 90 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Match in age (± 10 years), gender, and body mass index (± 20%, 18 kg/m^2 ≤ BMI ≤ 36 kg/m^2).

Who cannot join

Be a lactating female
Have received any investigational compound within 30 days prior to study dosing
Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance or individual's safety as judged by the investigator
Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody
Have poor venous access that limits phlebotomy
For Individuals with Renal Impairment

Show all 11Show fewer

Require or are anticipated to require dialysis within 90 days of study dosing
Require during the study or have received moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A within 2 weeks prior to study drug administration.
For Healthy Matched Controlled Individuals (Individuals with Normal Renal Function)
Have taken any prescription medications or over-the-counter medications, including herbal products and antacids, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications and/or stable hormone replacement therapy in peri- /post-menopausal female
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

United States3 sites

Clinical Pharmacology of Miami, Inc. (CPMI)
Miami, Florida
Omega Research Consultants, LLC
Orlando, Florida
Orlando Clinical Research Center
Orlando, Florida

Other trials in United States

New Zealand2 sites

Christchurch Clinical Studies Trust
Christchurch
Auckland Clinical Studies
Grafton, Auckland

Other trials in New Zealand

Germany1 site

APEX GmBH
Munich

Other trials in Germany

About this study

Official title: A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of GS-9876 in Subjects With Impaired Renal Function

Conditions: Inflammatory Disease
Being tested: Lanraplenib.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lanraplenib.Drug
Also called GS-9876
20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1

Study groups in NCT02959138
Study group	Role	What they receive
Moderate Renal Impairment (Cohort 1)	Experimental	Participants with moderate renal impairment and matched healthy controls will receive a single dose of lanraplenib Receives: Drug: Lanraplenib.
Severe Renal Impairment (Adaptive Cohort 2)	Experimental	Participants with severe renal impairment and matched healthy controls will receive a single dose of lanraplenib Receives: Drug: Lanraplenib.
Mild Renal Impairment (Adaptive Cohort 3)	Experimental	Participants with mild renal impairment and matched healthy controls will receive a single dose of lanraplenib Receives: Drug: Lanraplenib.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr
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
Measured: 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
PK Parameter: AUCinf of Lanraplenib Presented Based on Range of CLcr
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
Measured: 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
PK Parameter: Cmax of Lanraplenib Presented Based on Range of CLcr
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
Measured: 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

Secondary outcomes (2)

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
Measured: Day 1 up to Day 31
Percentage of Participants Who Experienced Graded Laboratory Abnormalities
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.
Measured: Day 1 up to Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20165 Oct 2018

First posted8 Nov 2016 (estimated)
Study start21 Nov 2016
Primary completion5 Oct 2018
Study completion5 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02959138
Sponsor's protocol ID: GS-US-379-1932
Other IDs: 2016-003823-47, 2016
Status last verified: Oct 2019
First submitted: 7 Nov 2016
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hsueh CH, Zheng H, Matzkies F, Mozaffarian A, Medzihradsky O, Tarnowski T, Curry N, and Mathias A. Pharmacokinetics and Short-Term Safety of GS-9876, an Oral Spleen Tyrosine Kinase Inhibitor in Subjects with Renal Impairment. American Society for Clinical Pharmacology and Therapeutics 2019; Washington D.C.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of GS-9876 in Subjects With Impaired Renal Function
ClinicalTrials.gov ID: NCT02959138
Acronym / sponsor ID: GS-US-379-1932
Conditions: Inflammatory Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 21 Nov 2016 (actual)
Primary completion: 5 Oct 2018 (actual)
Study completion: 5 Oct 2018 (actual)
First posted: 8 Nov 2016 (estimated)
Results: Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Moderate Renal Impairment (Cohort 1)	Experimental	Drug: Lanraplenib.Participants with moderate renal impairment and matched healthy controls will receive a single dose of lanraplenib
Severe Renal Impairment (Adaptive Cohort 2)	Experimental	Drug: Lanraplenib.Participants with severe renal impairment and matched healthy controls will receive a single dose of lanraplenib
Mild Renal Impairment (Adaptive Cohort 3)	Experimental	Drug: Lanraplenib.Participants with mild renal impairment and matched healthy controls will receive a single dose of lanraplenib

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

All Individuals
Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures
Have a calculated body mass index (BMI) of ≥ 18 kg/m^2 and ≤ 36 kg/m^2 at screening
Females of childbearing potential must have a negative pregnancy test at screening and clinic admission (Day -1).
Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.

Key exclusion criteria (11 listed)

Be a lactating female
Have received any investigational compound within 30 days prior to study dosing
Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance or individual's safety as judged by the investigator
Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody
Have poor venous access that limits phlebotomy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lanraplenib.Also: GS-987620 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1	Drug	Mild Renal Impairment (Adaptive Cohort 3), Moderate Renal Impairment (Cohort 1), Severe Renal Impairment (Adaptive Cohort 2)

Primary outcome

Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr
Time frame: 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
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
PK Parameter: AUCinf of Lanraplenib Presented Based on Range of CLcr
Time frame: 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
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
PK Parameter: Cmax of Lanraplenib Presented Based on Range of CLcr
Time frame: 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

2 secondary outcomes

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
Time frame: Day 1 up to Day 31
Percentage of Participants Who Experienced Graded Laboratory Abnormalities
Time frame: Day 1 up to Day 31

Results and safety

Results posted to the registry on 25 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate Renal Impairment	10	10
Severe Renal Impairment	10	9
Healthy Control	16	16

Primary outcome: Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr

Time frame: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Cohort 1: Moderate Renal Impairment n = 8	Cohort 1: Healthy Control n = 8	Cohort 2: Severe Renal Impairment n = 9	Cohort 2: Healthy Control n = 9
Value	2317.8 (813.83)	2027.4 (424.52)	2076.3 (812.99)	1871.6 (519.06)

Cohort 1: Moderate Renal Impairment vs Cohort 1: Healthy Control: GLSM ratio: 111.68 (90% CI 86.94 to 143.47)
Cohort 2: Severe Renal Impairment vs Cohort 2: Healthy Control: GLSM ratio: 107.04 (90% CI 78.47 to 146.02)

Population analysed: 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.

Primary outcome: PK Parameter: AUCinf of Lanraplenib Presented Based on Range of CLcr

Time frame: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Cohort 1: Moderate Renal Impairment n = 8	Cohort 1: Healthy Control n = 8	Cohort 2: Severe Renal Impairment n = 9	Cohort 2: Healthy Control n = 9
Value	2478.7 (908.61)	2153.0 (435.44)	2223.4 (855.97)	1994.2 (528.55)

Cohort 1: Moderate Renal Impairment vs Cohort 1: Healthy Control: GLSM ratio: 111.92 (90% CI 86.92 to 144.12)
Cohort 2: Severe Renal Impairment vs Cohort 2: Healthy Control: GLSM ratio: 107.69 (90% CI 79.63 to 145.65)

Population analysed: 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.

Primary outcome: PK Parameter: Cmax of Lanraplenib Presented Based on Range of CLcr

Time frame: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 1: Moderate Renal Impairment n = 8	Cohort 1: Healthy Control n = 8	Cohort 2: Severe Renal Impairment n = 9	Cohort 2: Healthy Control n = 9
Value	134.4 (35.47)	131.6 (33.71)	118.0 (38.97)	130.5 (30.77)

Cohort 1: Moderate Renal Impairment vs Cohort 1: Healthy Control: GLSM ratio: 102.00 (90% CI 81.42 to 127.79)
Cohort 2: Severe Renal Impairment vs Cohort 2: Healthy Control: GLSM ratio: 87.80 (90% CI 68.14 to 113.13)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 31. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Renal Impairment	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Severe Renal Impairment	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Healthy Control	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundHsueh CH, Zheng H, Matzkies F, Mozaffarian A, Medzihradsky O, Tarnowski T, Curry N, and Mathias A. Pharmacokinetics and Short-Term Safety of GS-9876, an Oral Spleen Tyrosine Kinase Inhibitor in Subjects with Renal Impairment. American Society for Clinical Pharmacology and Therapeutics 2019; Washington D.C.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lanraplenib. in people with Inflammatory Disease, run by Gilead Sciences at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, New Zealand, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02959138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.