COVID-19Phase 1NCT04859244
First-in-Human Study of Orally Administered GS-441524 for COVID-19
A Phase 1 study testing GS-441524 in people with COVID-19, run by Copycat Sciences LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- GS-441524
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- GS-441524
- Keywords
- GS-441524, remdesivir, GS-5734, Copycat Sciences, Gilead Sciences, COVID-19, antiviral
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-441524Drug
Also called Parent nucleoside of remdesivir
750 mg administered as a solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: GS-441524 (QD, 7 days) | Experimental | 750 mg GS-441524 administered QD for 7 days Receives: Drug: GS-441524 |
| Part 2: GS-441524 (TID, 3 days) | Experimental | 750 mg GS-441524 administered TID for 3 days Receives: Drug: GS-441524 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence of treatment-related adverse events (AEs)
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
Measured: Day 7
Secondary outcomes (8)
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.
Measured: Intensive PK: Day 1 to Day 7
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Intensive PK: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copycat Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Yan, Principal investigator, Copycat Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859244
- Sponsor's protocol ID
- CC-2021-001
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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.
PubMed 32589775Tempestilli 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.
PubMed 32607555Davis 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.
PubMed 33152758Yan 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.
PubMed 32665809
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
- ClinicalTrials.gov ID
- NCT04859244
- Acronym / sponsor ID
- CC-2021-001
- Conditions
- COVID-19
- Keywords
- GS-441524, remdesivir, GS-5734, Copycat Sciences, Gilead Sciences, COVID-19, antiviral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Copycat Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: GS-441524 (QD, 7 days) | Experimental | Drug: GS-441524750 mg GS-441524 administered QD for 7 days |
| Part 2: GS-441524 (TID, 3 days) | Experimental | Drug: GS-441524750 mg GS-441524 administered TID for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-441524Also: Parent nucleoside of remdesivir750 mg administered as a solution | Drug | Part 1: GS-441524 (QD, 7 days), Part 2: GS-441524 (TID, 3 days) |
Primary outcome
Emergence of treatment-related adverse events (AEs)
Time frame: Day 7
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
8 secondary outcomes
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Clast of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
Time frame: Intensive PK: Day 1 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Background: PubMed 32589775Humeniuk 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.
- Background: PubMed 32607555Tempestilli 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.
- Background: PubMed 33152758Davis 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.
- Background: PubMed 32665809Yan 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.
- Preliminary resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Yan principal investigator
Copycat Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-441524 in people with COVID-19, run by Copycat Sciences LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence of treatment-related adverse events (AEs) (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.