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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: GS-441524

• Registration Number: NCT04859244
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Primary Completion: 2021-05-01
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-07
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2: GS-441524 (TID, 3 days)	GS-441524	750 mg GS-441524 administered TID for 3 days
Part 1: GS-441524 (QD, 7 days)	GS-441524	750 mg GS-441524 administered QD for 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.	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.	Intensive PK: Day 1 to Day 7	T/2 is defined as the estimate of the terminal elimination half-life of the drug
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.	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: Cmax of GS-441524 in Parts 1 and 2.	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.	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.	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.	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.	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).

Trial Locations

Locations (1)

Copycat Sciences Study Site; 🇺🇸 Houston, Texas, United States