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NCT04859244 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04859244
Other study ID # CC-2021-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 1, 2021
Est. completion date August 1, 2021

Study information
Verified date April 2021
Source Copycat Sciences LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date August 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• GS-441524
750 mg administered as a solution

Locations
Country Name City State
United States Copycat Sciences Study Site Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Copycat Sciences LLC

Country where clinical trial is conducted

United States, 

References & Publications (4)

Davis MR, Pham CU, Cies JJ. Remdesivir and GS-441524 plasma concentrations in patients with end-stage renal disease on haemodialysis. J Antimicrob Chemother. 2021 Feb 11;76(3):822-825. doi: 10.1093/jac/dkaa472. — View Citation

Humeniuk R, Mathias A, Cao H, Osinusi A, Shen G, Chng E, Ling J, Vu A, German P. Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):896-906. doi: 10.1111/cts.12840. Epub 2020 Aug 5. — View Citation

Tempestilli M, Caputi P, Avataneo V, Notari S, Forini O, Scorzolini L, Marchioni L, Ascoli Bartoli T, Castilletti C, Lalle E, Capobianchi MR, Nicastri E, D'Avolio A, Ippolito G, Agrati C; COVID 19 INMI Study Group. Pharmacokinetics of remdesivir and GS-441524 in two critically ill patients who recovered from COVID-19. J Antimicrob Chemother. 2020 Oct 1;75(10):2977-2980. doi: 10.1093/jac/dkaa239. — View Citation

Yan VC, Muller FL. Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment. ACS Med Chem Lett. 2020 Jun 23;11(7):1361-1366. doi: 10.1021/acsmedchemlett.0c00316. eCollection 2020 Jul 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Emergence of treatment-related adverse events (AEs) Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG. Day 7
Secondary Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2. AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: AUClast of GS-441524 in Parts 1 and 2. AUClast is defined as the concentration of drug from time zero to the last observable concentration. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: T1/2 of GS-441524 in Parts 1 and 2. T/2 is defined as the estimate of the terminal elimination half-life of the drug Intensive PK: Day 1 to Day 7
Secondary PK Parameter: Cmax of GS-441524 in Parts 1 and 2. Cmax is defined as the maximum observed concentration of drug. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: Tmax of GS-441524 in Parts 1 and 2. Tmax is defined as the time (observed time point) of Cmax. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: Clast of GS-441524 in Parts 1 and 2. Clast is defined as the last observable concentration of drug. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: Tlast of GS-441524 in Parts 1 and 2. Tlast is defined as the time (observed time point) of Clast. Intensive PK: Day 1 to Day 7
Secondary PK Parameter: AUCtau of GS-441524 in Parts 1 and 2. AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Intensive PK: Day 1 to Day 7
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