Healthy Volunteers StudyPhase 1NCT05137626
Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)
A Phase 1 study testing AT-527 + digoxin in people with Healthy Volunteers Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Drug-drug interaction study of Digoxin and AT-527 (R07496998) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Study
- What is being tested?
- AT-527 + digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2021to 12 Dec 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Females must have a 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
- Willing to comply with the study requirements and to provide written informed consent
Who cannot join
- Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Concomitant use of prescription medications, or systemic over-the-counter medications
- Other clinically significant medical conditions or laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects
Drug-drug interaction study of Digoxin and AT-527 (R07496998)
- Conditions
- Healthy Volunteers Study
- Being tested
- AT-527 + digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527 + digoxinDrug
Also called AT-527 is also know as R07496998
- Day 1: A single dose of digoxin will be administered.
- Day 15: A single dose of AT-527 and digoxin will be co-administered.
AT-527 + digoxinDrug
Also called AT-527 is also know as R07496998
- Day 1: A single dose of digoxin will be administered.
- Day 15: A single staggered dose of AT-527 and digoxin will be administered (2 hours later).
| Study group | Role | What they receive |
|---|---|---|
| AT-527 + digoxin (simultaneous) | Experimental | n=14 Receives: Drug: AT-527 + digoxin |
| AT-527 + digoxin (staggered) | Experimental | n=14 Receives: Drug: AT-527 + digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 15
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
Area under the concentration-time curve (AUC)
Measured: Day 1, Day 15
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 15
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
Area under the concentration-time curve (AUC)
Measured: Day 1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start3 Nov 2021
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers StudyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137626
- Sponsor's protocol ID
- AT-03A-013
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05137626
- Acronym / sponsor ID
- AT-03A-013
- Conditions
- Healthy Volunteers Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 30 Nov 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.
Drug-drug interaction study of Digoxin and AT-527 (R07496998)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT-527 + digoxin (simultaneous) | Experimental | Drug: AT-527 + digoxinn=14 |
| AT-527 + digoxin (staggered) | Experimental | Drug: AT-527 + digoxinn=14 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Females must have a 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
- Willing to comply with the study requirements and to provide written informed consent
Key exclusion criteria (5 listed)
- Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Concomitant use of prescription medications, or systemic over-the-counter medications
- 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 |
|---|---|---|
| AT-527 + digoxinAlso: AT-527 is also know as R07496998* Day 1: A single dose of digoxin will be administered. * Day 15: A single dose of AT-527 and digoxin will be co-administered. | Drug | AT-527 + digoxin (simultaneous) |
| AT-527 + digoxinAlso: AT-527 is also know as R07496998* Day 1: A single dose of digoxin will be administered. * Day 15: A single staggered dose of AT-527 and digoxin will be administered (2 hours later). | Drug | AT-527 + digoxin (staggered) |
Primary outcome
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
Time frame: Day 1, Day 15
Maximum plasma concentration (Cmax)
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin
Time frame: Day 1, Day 15
Area under the concentration-time curve (AUC)
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
Time frame: Day 1, Day 15
Maximum plasma concentration (Cmax)
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin
Time frame: Day 1, Day 15
Area under the concentration-time curve (AUC)
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 28 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AT-527 + digoxin in people with Healthy Volunteers Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
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 4 inclusion and 5 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 28 Feb 2022. 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 Canada. 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?
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin (time frame: Day 1, Day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2022.