NCT04859244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 10, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 19, 2021

Last Update Submit

August 7, 2021

Conditions

COVID-19

Keywords

GS-441524remdesivirGS-5734Copycat SciencesGilead SciencesCOVID-19antiviral

Outcome Measures

Primary Outcomes (1)

  • Emergence of treatment-related adverse events (AEs)

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

    Day 7

Secondary Outcomes (8)

  • Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.

    Intensive PK: Day 1 to Day 7

  • PK Parameter: AUClast of GS-441524 in Parts 1 and 2.

    Intensive PK: Day 1 to Day 7

  • PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.

    Intensive PK: Day 1 to Day 7

  • PK Parameter: Cmax of GS-441524 in Parts 1 and 2.

    Intensive PK: Day 1 to Day 7

  • PK Parameter: Tmax of GS-441524 in Parts 1 and 2.

    Intensive PK: Day 1 to Day 7

  • +3 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

750 mg GS-441524 administered QD for 7 days

Drug: GS-441524

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

EXPERIMENTAL

750 mg GS-441524 administered TID for 3 days

Drug: GS-441524

Interventions

GS-441524DRUG

750 mg administered as a solution

Also known as: Parent nucleoside of remdesivir
Part 1: GS-441524 (QD, 7 days)Part 2: GS-441524 (TID, 3 days)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copycat Sciences Study Site

Houston, Texas, 77054, United States

Location

Related Publications (4)

  • 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.

    PMID: 32589775BACKGROUND

  • 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.

    PMID: 32607555BACKGROUND

  • 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.

    PMID: 33152758BACKGROUND

  • 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.

    PMID: 32665809BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

GS-441524

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Victoria Yan

    Copycat Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 26, 2021

Study Start

January 1, 2021

Primary Completion

May 1, 2021

Study Completion

August 1, 2021

Last Updated

August 10, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within 6 months after publication
Access Criteria
Materials available upon request

Available IPD Datasets

Individual Participant Data Set Access

Locations

US(1)