search
Back to results

First-in-Human Study of Orally Administered GS-441524 for COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-441524
Sponsored by
Copycat Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring GS-441524, remdesivir, GS-5734, Copycat Sciences, Gilead Sciences, COVID-19, antiviral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Negative pregnancy test at screening and prior to dosing
  • Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

  • Use of other investigational drugs within 28 days of dosing
  • Positive pregnancy test
  • Abuse of alcohol or drugs
  • Other clinically significant medical conditions or laboratory abnormalities

Sites / Locations

  • Copycat Sciences Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: GS-441524 (QD, 7 days)

Part 2: GS-441524 (TID, 3 days)

Arm Description

750 mg GS-441524 administered QD for 7 days

750 mg GS-441524 administered TID for 3 days

Outcomes

Primary Outcome Measures

Emergence of treatment-related adverse events (AEs)
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.

Secondary Outcome Measures

Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours.
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
T/2 is defined as the estimate of the terminal elimination half-life of the drug
PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
Cmax is defined as the maximum observed concentration of drug.
PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
Tmax is defined as the time (observed time point) of Cmax.
PK Parameter: Clast of GS-441524 in Parts 1 and 2.
Clast is defined as the last observable concentration of drug.
PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
Tlast is defined as the time (observed time point) of Clast.
PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Full Information

First Posted
April 19, 2021
Last Updated
August 7, 2021
Sponsor
Copycat Sciences LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04859244
Brief Title
First-in-Human Study of Orally Administered GS-441524 for COVID-19
Official Title
First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copycat Sciences LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.
Detailed Description
Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
GS-441524, remdesivir, GS-5734, Copycat Sciences, Gilead Sciences, COVID-19, antiviral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: GS-441524 (QD, 7 days)
Arm Type
Experimental
Arm Description
750 mg GS-441524 administered QD for 7 days
Arm Title
Part 2: GS-441524 (TID, 3 days)
Arm Type
Experimental
Arm Description
750 mg GS-441524 administered TID for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-441524
Other Intervention Name(s)
Parent nucleoside of remdesivir
Intervention Description
750 mg administered as a solution
Primary Outcome Measure Information:
Title
Emergence of treatment-related adverse events (AEs)
Description
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
Description
AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
Description
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
Description
T/2 is defined as the estimate of the terminal elimination half-life of the drug
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
Description
Cmax is defined as the maximum observed concentration of drug.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
Description
Tmax is defined as the time (observed time point) of Cmax.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: Clast of GS-441524 in Parts 1 and 2.
Description
Clast is defined as the last observable concentration of drug.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
Description
Tlast is defined as the time (observed time point) of Clast.
Time Frame
Intensive PK: Day 1 to Day 7
Title
PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
Description
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame
Intensive PK: Day 1 to Day 7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent Negative pregnancy test at screening and prior to dosing Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 Exclusion Criteria: Use of other investigational drugs within 28 days of dosing Positive pregnancy test Abuse of alcohol or drugs Other clinically significant medical conditions or laboratory abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Yan
Organizational Affiliation
Copycat Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copycat Sciences Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD
IPD Sharing Time Frame
Within 6 months after publication
IPD Sharing Access Criteria
Materials available upon request
Citations:
PubMed Identifier
32589775
Citation
Humeniuk R, Mathias A, Cao H, Osinusi A, Shen G, Chng E, Ling J, Vu A, German P. Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):896-906. doi: 10.1111/cts.12840. Epub 2020 Aug 5.
Results Reference
background
PubMed Identifier
32607555
Citation
Tempestilli M, Caputi P, Avataneo V, Notari S, Forini O, Scorzolini L, Marchioni L, Ascoli Bartoli T, Castilletti C, Lalle E, Capobianchi MR, Nicastri E, D'Avolio A, Ippolito G, Agrati C; COVID 19 INMI Study Group. Pharmacokinetics of remdesivir and GS-441524 in two critically ill patients who recovered from COVID-19. J Antimicrob Chemother. 2020 Oct 1;75(10):2977-2980. doi: 10.1093/jac/dkaa239.
Results Reference
background
PubMed Identifier
33152758
Citation
Davis MR, Pham CU, Cies JJ. Remdesivir and GS-441524 plasma concentrations in patients with end-stage renal disease on haemodialysis. J Antimicrob Chemother. 2021 Feb 11;76(3):822-825. doi: 10.1093/jac/dkaa472. No abstract available.
Results Reference
background
PubMed Identifier
32665809
Citation
Yan VC, Muller FL. Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment. ACS Med Chem Lett. 2020 Jun 23;11(7):1361-1366. doi: 10.1021/acsmedchemlett.0c00316. eCollection 2020 Jul 9.
Results Reference
background
Links:
URL
https://osf.io/am5s8/
Description
Preliminary results
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://osf.io/am5s8/
Available IPD/Information Comments
Supplementary Table 1: Blood chemistry (CBC, CMP) results. Supplementary Table 2: Plasma concentrations of GS-441524 at indicated timepoints.

Learn more about this trial

First-in-Human Study of Orally Administered GS-441524 for COVID-19

We'll reach out to this number within 24 hrs