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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 : Completed
First Posted : April 26, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Copycat Sciences LLC

Tracking Information
First Submitted Date  ICMJE April 19, 2021
First Posted Date  ICMJE April 26, 2021
Last Update Posted Date August 10, 2021
Actual Study Start Date  ICMJE January 1, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2021)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study of Orally Administered GS-441524 for COVID-19
Official Title  ICMJE First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: GS-441524
750 mg administered as a solution
Other Name: Parent nucleoside of remdesivir
Study Arms  ICMJE
  • Experimental: Part 1: GS-441524 (QD, 7 days)
    750 mg GS-441524 administered QD for 7 days
    Intervention: Drug: GS-441524
  • Experimental: Part 2: GS-441524 (TID, 3 days)
    750 mg GS-441524 administered TID for 3 days
    Intervention: Drug: GS-441524
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2021)
1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2021
Actual Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04859244
Other Study ID Numbers  ICMJE CC-2021-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected IPD
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Within 6 months after publication
Access Criteria: Materials available upon request
Current Responsible Party Copycat Sciences LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Copycat Sciences LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victoria Yan Copycat Sciences
PRS Account Copycat Sciences LLC
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP