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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04859244
Recruitment Status : Active, not recruiting
First Posted : April 26, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Copycat Sciences LLC

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: GS-441524 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

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 Name: 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 Name: Parent nucleoside of remdesivir




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  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.

  8. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859244


Locations
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United States, Texas
Copycat Sciences Study Site
Houston, Texas, United States, 77054
Sponsors and Collaborators
Copycat Sciences LLC
Investigators
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Principal Investigator: Victoria Yan Copycat Sciences
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Supplementary Table 1: Blood chemistry (CBC, CMP) results. Supplementary Table 2: Plasma concentrations of GS-441524 at indicated timepoints.

Publications:
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Responsible Party: Copycat Sciences LLC
ClinicalTrials.gov Identifier: NCT04859244    
Other Study ID Numbers: CC-2021-001
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 6 months after publication
Access Criteria: Materials available upon request

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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
Keywords provided by Copycat Sciences LLC:
GS-441524
remdesivir
GS-5734
Copycat Sciences
Gilead Sciences
COVID-19
antiviral