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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04859244
Status
Completed
Sponsor
Copycat Sciences LLC

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.