Pharmacokinetics of GS-9876 in Adults With Impaired Renal Function



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:11/28/2018
Start Date:November 21, 2016
End Date:October 5, 2018

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

The primary objective of this study is to evaluate the pharmacokinetics (PK) of GS-9876 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.


Key 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

- Be between 18 through 75 years of age, inclusive at screening

- 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 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
{Cockcroft et al 1976}) based on serum creatinine and actual body weight as measured
at screening.

For Healthy Matched Controlled Individuals (Individuals with Normal Renal Function)

- Have a creatinine clearance (CLcr) ≥ 90 mL/min (using the Cockcroft-Gault method
{Cockcroft et al 1976}) 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).

Key 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
CYP3A 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.
We found this trial at
4
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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476 Landsberger Straße
Munich, 81241
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Orlando, Florida 32804
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Orlando, FL
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