Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001048976
Ethics application status
Approved
Date submitted
15/09/2020
Date registered
15/10/2020
Date last updated
22/10/2021
Date data sharing statement initially provided
15/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to
Evaluate the Pharmacokinetics of Remdesivir and Metabolites in
Participants with Normal Renal Function and Renal Impairment
Scientific title
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to
Evaluate the Pharmacokinetics of Remdesivir and Metabolites in
Participants with Normal Renal Function and Renal Impairment
Secondary ID [1] 302283 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 319028 0
Condition category
Condition code
Respiratory 316982 316982 0 0
Other respiratory disorders / diseases
Infection 317355 317355 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318570 0
Treatment: Drugs
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325091 0
PK parameters, via urine samples, Cmax, AUClast, AUCinf or AUC0-t of RDV
Timepoint [1] 325091 0
Intensive PK sampling will occur relative to the start time of RDV infusion at the following time points: Predose ( 5 min), 0.25 (middle of infusion), 0.5 (end of infusion), 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose.
Secondary outcome [1] 386826 0
Incidences of AEs including Nausea, Acute respiratory failure and Acute Kidney Injury will be assessed by physical examination and or patient questioning
Timepoint [1] 386826 0
Screening, Day -1, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 18
Secondary outcome [2] 386827 0
laboratory abnormalities will be assessed using Coagulation Panel, Hematology, Chemistry, Urinalysis.
Timepoint [2] 386827 0
Days 2, 5, 8, 11

Eligibility
Key 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
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
26/07/2021
Date of last participant enrolment
Anticipated
25/02/2022
Actual
Date of last data collection
Anticipated
16/03/2022
Actual
Sample size
Target
80
Accrual to date
41
Final
Recruitment outside Australia
Country [1] 22977 0
New Zealand
State/province [1] 22977 0
Country [2] 22978 0
Germany
State/province [2] 22978 0
Country [3] 22979 0
United States of America
State/province [3] 22979 0
Country [4] 22980 0
Puerto Rico
State/province [4] 22980 0

Funding & Sponsors
Funding source category [1] 306709 0
Commercial sector/Industry
Name [1] 306709 0
Gilead Sciences Inc
Country [1] 306709 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences Inc
Address
333 Lakeside Drive
Foster City, CA USA 94404
Country
United States of America
Secondary sponsor category [1] 307257 0
None
Name [1] 307257 0
Address [1] 307257 0
Country [1] 307257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306879 0
New Zealand Central Health and Disability Ethics Committee
Ethics committee address [1] 306879 0
Ground Floor
Ministry of Health
133 Molesworth St
Wellington 2820
Ethics committee country [1] 306879 0
New Zealand
Date submitted for ethics approval [1] 306879 0
15/10/2020
Approval date [1] 306879 0
19/02/2021
Ethics approval number [1] 306879 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105322 0
Dr Michael Collins
Address 105322 0
Auckland Clinical Studies
3 Ferncroft St, Grafton, Auckland 1010
Country 105322 0
New Zealand
Phone 105322 0
+6493733474
Fax 105322 0
Email 105322 0
[email protected]
Contact person for public queries
Name 105323 0
Mrs Mary Ellis-Pegler
Address 105323 0
Auckland Clinical Studies
3 Ferncroft St, Grafton, Auckland 1010
Country 105323 0
New Zealand
Phone 105323 0
+6493733474
Fax 105323 0
Email 105323 0
[email protected]
Contact person for scientific queries
Name 105324 0
Dr Michael Collins
Address 105324 0
Auckland Clinical Studies
3 Ferncroft St, Grafton, Auckland 1010
Country 105324 0
New Zealand
Phone 105324 0
+6493733474
Fax 105324 0
Email 105324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data will be used for Regulatory Authorities submissions to government bodies.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.