Clinical trial NCT04859244: First-in-Human Study of Orally Administered GS-441524 for COVID-19
Official title: First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: GS-441524
remdesivir
GS-5734
Copycat Sciences
Gilead Sciences
COVID-19
antiviral
Lead sponsor: Copycat Sciences LLC
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Emergence of treatment-related adverse events (AEs)
timeFrame: Day 7
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: Clast of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
measure: PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
timeFrame: Intensive PK: Day 1 to Day 7
Other outcomes:
Locations:
city: Houston
country: United States
facility: Copycat Sciences Study Site
state: Texas
Study officials:
affiliation: Copycat Sciences
name: Victoria Yan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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. No abstract available.
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.