Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function

NCT ID: NCT02959138

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-21
• Study Completion Date: 2018-10-05

Brief 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.

Conditions

Inflammatory Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Renal Impairment (Cohort 1)

Participants with moderate renal impairment and matched healthy controls will receive a single dose of lanraplenib

Group Type: EXPERIMENTAL

Lanraplenib.

Intervention Type: DRUG

20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1

Severe Renal Impairment (Adaptive Cohort 2)

Participants with severe renal impairment and matched healthy controls will receive a single dose of lanraplenib

Group Type: EXPERIMENTAL

Lanraplenib.

Intervention Type: DRUG

20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1

Mild Renal Impairment (Adaptive Cohort 3)

Participants with mild renal impairment and matched healthy controls will receive a single dose of lanraplenib

Group Type: EXPERIMENTAL

Lanraplenib.

Intervention Type: DRUG

20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1

Interventions

Lanraplenib.

20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1

Intervention Type: DRUG

Other Intervention Names

GS-9876

Eligibility Criteria

Inclusion Criteria

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
• 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).

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Clinical Pharmacology of Miami, Inc. (CPMI)

Miami, Florida, United States

Omega Research Consultants, LLC

Orlando, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

APEX GmBH

Munich, , Germany

Auckland Clinical Studies

Grafton, Auckland, New Zealand

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Countries

United States; Germany; New Zealand

References

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol: Amendment 1

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003823-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-379-1932

Identifier Type: -

Identifier Source: org_study_id