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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: GS-441524 (QD, 7 days) | Experimental | 750 mg GS-441524 administered QD for 7 days |
|
| Part 2: GS-441524 (TID, 3 days) | Experimental | 750 mg GS-441524 administered TID for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-441524 | Drug | 750 mg administered as a solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PK Parameter: AUClast of GS-441524 in Parts 1 and 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Yan | Copycat Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copycat Sciences Study Site | Houston | Texas | 77054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32589775 | Background | 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. | |
| 32607555 | Background | 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. |
| Label | URL |
|---|---|
| Preliminary results | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
All collected IPD
Within 6 months after publication
Materials available upon request
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000710751 | GS-441524 |
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
| Intensive PK: Day 1 to Day 7 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 33152758 | Background | 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. |
| 32665809 | Background | 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. |
Supplementary Table 1: Blood chemistry (CBC, CMP) results. Supplementary Table 2: Plasma concentrations of GS-441524 at indicated timepoints. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |