None listed
Conditions
Brief summary
The current study is an open-label, parallel-group, single-dose study. This study will be conducted in non-COVID-19-infected population and within a confined Phase 1 unit. This design will allow for more robust evaluation of the effect of reduced renal function on PK of RDV and metabolites relative to the matched healthy participants with normal renal function without the potential confounding effects of target disease. Four cohorts are planned for this study, each enrolling 10 participants with reduced renal function. Each renally impaired participant will have a matched participant enrolled with normal renal function in the matched group (matched for age, gender, and body mass index [BMI]). Participants with normal renal function can serve as a control for other cohorts, as long as the RDV dose is the same and the matching criteria are met.
Interventions
Participants in all cohorts (impaired renal function and matched normal renal function) will receive a single dose of 100 mg Remdesivir on Day 1 in the morning, IV infusion for 30 minutes ± 5 minutes. The participants will be supervised by a health care professional during the infusion and will be confined to the clinic for up to 11 days.
Sponsors
Gilead Sciences Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Outcome results
None listed