Healthy Volunteer StudyPhase 1NCT05256732
Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
A Phase 1 study testing AT-527 fasted, AT-527 fed and AT-527 in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AT-527 fasted, AT-527 fed and AT-527
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2022to 23 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Other clinically significant medical conditions or laboratory abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects
- Conditions
- Healthy Volunteer Study
- Being tested
- AT-527 fasted, Placebo Comparator fasted, AT-527 fed, Placebo Comparator fed, AT-527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527 fastedDrug
Also called Bemnifosbuvir
AT-527 administered twice daily (BID) for 5 days fasted
Placebo Comparator fastedOther
Matching placebo administered twice daily (BID) for 5 days fasted
AT-527 fedDrug
Also called Bemnifosbuvir
AT-527 administered twice daily (BID) for 5 days fed
Placebo Comparator fedOther
Matching placebo administered twice daily (BID) for 5 days fed
AT-527Drug
Also called Bemnifosbuvir
AT-527 administered twice daily (BID)
AT-527 single doseDrug
Also called Bemnifosbuvir
AT-527 single dose fasted/fed cross-over
| Study group | Role | What they receive |
|---|---|---|
| AT-527 | Experimental | Not described Receives: Drug: AT-527 fasted; Drug: AT-527 fed |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator fasted; Other: Placebo Comparator fed |
| AT-527 BID | Experimental | Not described Receives: Drug: AT-527 |
| AT-527 single dose fasted/fed | Experimental | Not described Receives: Drug: AT-527 single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of AT-527
Maximum plasma concentration (Cmax)
Measured: Day 1
Pharmacokinetics (PK) of AT-527
Area under the concentration-time curve (AUC)
Measured: Day 1
Pharmacokinetics (PK) of AT-527
Trough plasma concentration (Ctrough)
Measured: Day 1
Proportions of subjects experiencing treatment-emergent adverse events
Measured: Day 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start22 Feb 2022
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256732
- Sponsor's protocol ID
- AT-03A-015
- Status last verified
- Oct 2022
- First submitted
- 16 Feb 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05256732
- Acronym / sponsor ID
- AT-03A-015
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 25 Feb 2022 (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 study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AT-527 | Experimental | Drug: AT-527 fasted, Drug: AT-527 fed |
| Placebo | Placebo comparator | Other: Placebo Comparator fasted, Other: Placebo Comparator fed |
| AT-527 BID | Experimental | Drug: AT-527 |
| AT-527 single dose fasted/fed | Experimental | Drug: AT-527 single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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)
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- 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 fastedAlso: BemnifosbuvirAT-527 administered twice daily (BID) for 5 days fasted | Drug | AT-527 |
| Placebo Comparator fastedMatching placebo administered twice daily (BID) for 5 days fasted | Other | Placebo |
| AT-527 fedAlso: BemnifosbuvirAT-527 administered twice daily (BID) for 5 days fed | Drug | AT-527 |
| Placebo Comparator fedMatching placebo administered twice daily (BID) for 5 days fed | Other | Placebo |
| AT-527Also: BemnifosbuvirAT-527 administered twice daily (BID) | Drug | AT-527 BID |
| AT-527 single doseAlso: BemnifosbuvirAT-527 single dose fasted/fed cross-over | Drug | AT-527 single dose fasted/fed |
Primary outcome
Pharmacokinetics (PK) of AT-527
Time frame: Day 1
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527
Time frame: Day 1
Area under the concentration-time curve (AUC)
Pharmacokinetics (PK) of AT-527
Time frame: Day 1
Trough plasma concentration (Ctrough)
Proportions of subjects experiencing treatment-emergent adverse events
Time frame: Day 1-10
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 18 Oct 2022.
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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 fasted, AT-527 fed and AT-527 in people with Healthy Volunteer 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 18 Oct 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetics (PK) of AT-527 (time frame: Day 1). 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 18 Oct 2022.