Healthy Volunteer StudyPhase 1NCT04784000
Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
A Phase 1 study testing Period 1: AT-527 550 mg, Period 2: carbamazepine and Period 3: AT-527 550 mg + carbamazepine in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) 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?
- Period 1: AT-527 550 mg, Period 2: carbamazepine and Period 3: AT-527 550 mg + carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 10 Apr 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 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 18-29 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
- Use of other prescription drugs with 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: A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.
- Conditions
- Healthy Volunteer Study
- Being tested
- Period 1: AT-527 550 mg, Period 2: carbamazepine, Period 3: AT-527 550 mg + carbamazepine, Period 3: AT-527 1100 mg + carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1: AT-527 550 mgDrug
Also called AT-527 is also known as RO7496998
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
Period 2: carbamazepineDrug
Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25
Period 3: AT-527 550 mg + carbamazepineDrug
Also called AT-527 is also known as RO7496998
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Period 3: AT-527 1100 mg + carbamazepineDrug
Also called AT-527 is also known as RO7496998
AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
| Study group | Role | What they receive |
|---|---|---|
| AT-527 550 mg + carbamezepine | Experimental | Not described Receives: Drug: Period 1: AT-527 550 mg; Drug: Period 2: carbamazepine; Drug: Period 3: AT-527 550 mg + carbamazepine |
| AT-527 1100 mg + carbamezepine | Experimental | Not described Receives: Drug: Period 1: AT-527 550 mg; Drug: Period 2: carbamazepine; Drug: Period 3: AT-527 1100 mg + carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of AT-527 (RO7496998)
Maximum plasma concentration (Cmax)
Measured: Day 1 vs Day 26
Pharmacokinetics (PK) of AT-527 (RO7496998)
Area under the concentration-time curve (AUC)
Measured: Day 1 vs Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Mar 2021
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT04784000
- Sponsor's protocol ID
- AT-03A-004
- Status last verified
- Jul 2021
- First submitted
- 3 Mar 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04784000
- Acronym / sponsor ID
- AT-03A-004
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 5 Mar 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 study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT-527 550 mg + carbamezepine | Experimental | Drug: Period 1: AT-527 550 mg, Drug: Period 2: carbamazepine, Drug: Period 3: AT-527 550 mg + carbamazepine |
| AT-527 1100 mg + carbamezepine | Experimental | Drug: Period 1: AT-527 550 mg, Drug: Period 2: carbamazepine, Drug: Period 3: AT-527 1100 mg + carbamazepine |
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 18-29 kg/m2
- Willing to comply with the study requirements and to provide written informed consent
Key exclusion criteria (6 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
- Use of other prescription drugs with 28 days of dosing
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 |
|---|---|---|
| Period 1: AT-527 550 mgAlso: AT-527 is also known as RO7496998AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1 | Drug | AT-527 1100 mg + carbamezepine, AT-527 550 mg + carbamezepine |
| Period 2: carbamazepineCarbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25 | Drug | AT-527 1100 mg + carbamezepine, AT-527 550 mg + carbamezepine |
| Period 3: AT-527 550 mg + carbamazepineAlso: AT-527 is also known as RO7496998AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 | Drug | AT-527 550 mg + carbamezepine |
| Period 3: AT-527 1100 mg + carbamazepineAlso: AT-527 is also known as RO7496998AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 | Drug | AT-527 1100 mg + carbamezepine |
Primary outcome
Pharmacokinetics (PK) of AT-527 (RO7496998)
Time frame: Day 1 vs Day 26
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527 (RO7496998)
Time frame: Day 1 vs Day 26
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 29 Jul 2021.
Related trials for Healthy Volunteer Study
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Screening Protocol
Pain
RecruitingPhase 1
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Neoplasms, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
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 Period 1: AT-527 550 mg, Period 2: carbamazepine and Period 3: AT-527 550 mg + carbamazepine 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 6 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 29 Jul 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 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?
Pharmacokinetics (PK) of AT-527 (RO7496998) (time frame: Day 1 vs Day 26). The study lists 2 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 29 Jul 2021.