A Phase 1 Open-Label, Parallel-Group, Single-Dose Study toEvaluate the Pharmacokinetics of Remdesivir and Metabolites inParticipants with Normal Renal Function and Renal Impairment

Phase 1

Recruiting

• Conditions: COVID-19; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12620001048976
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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 BMI of BMI 18 to 38 kg/m2 at screening

Participants with renal impairment must also meet the following additional inclusion criteria to
be eligible for participation in this study:
Have renal impairment classification at screening that has been unchanged during the
3 months prior to screening
eGFR must be the following (using the MDRD equation) based on serum creatinine (Scr) as
measured at the screening evaluation:
Mild Renal Impairment: eGFRMDRD 60-89 mL/min/1.73m2
Moderate Renal Impairment: eGFRMDRD 30-59 mL/min/1.73m2
Severe Renal Impairment: eGFRMDRD < 30 mL/min/1.73m2
ESRD: eGFRMDRD < 15 mL/min/1.73m2 on chronic HD

Exclusion Criteria

Positive serum pregnancy test

Lactating female

Any prior exposure to RDV, unless allowed by the sponsor

Have current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance or participant safety, or a positive drug or alcohol test at
screening or baseline

Have a positive test result for human immunodeficiency virus type 1 (HIV-1)/human
immunodeficiency virus type 2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C
virus (HCV) antibody with concurrent positive viral load at screening

Have poor venous access that limits phlebotomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified