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

August 7, 2021 updated by: Copycat Sciences LLC

First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • Copycat Sciences Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: GS-441524 (QD, 7 days)
750 mg GS-441524 administered QD for 7 days
Drug: GS-441524
750 mg administered as a solution
Other Names:
  • Parent nucleoside of remdesivir
Experimental: Part 2: GS-441524 (TID, 3 days)
750 mg GS-441524 administered TID for 3 days
Drug: GS-441524
750 mg administered as a solution
Other Names:
  • Parent nucleoside of remdesivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence of treatment-related adverse events (AEs)
Time Frame: Day 7
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours.
Intensive PK: Day 1 to Day 7
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Intensive PK: Day 1 to Day 7
PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
T/2 is defined as the estimate of the terminal elimination half-life of the drug
Intensive PK: Day 1 to Day 7
PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
Cmax is defined as the maximum observed concentration of drug.
Intensive PK: Day 1 to Day 7
PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
Tmax is defined as the time (observed time point) of Cmax.
Intensive PK: Day 1 to Day 7
PK Parameter: Clast of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
Clast is defined as the last observable concentration of drug.
Intensive PK: Day 1 to Day 7
PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
Tlast is defined as the time (observed time point) of Clast.
Intensive PK: Day 1 to Day 7
PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
Time Frame: Intensive PK: Day 1 to Day 7
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Intensive PK: Day 1 to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copycat Sciences LLC

Investigators

  • Principal Investigator: Victoria Yan, Copycat Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

Within 6 months after publication

IPD Sharing Access Criteria

Materials available upon request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: Supplementary Table 1: Blood chemistry (CBC, CMP) results. Supplementary Table 2: Plasma concentrations of GS-441524 at indicated timepoints.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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