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Completed

NCT Number: NCT04859244

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Copycat Sciences Study Site

Houston, Texas, 77054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-441524

Drug

750 mg administered as a solution

Other names: Parent nucleoside of remdesivir

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Copycat Sciences LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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