Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
NCT ID: NCT04784000
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2021-03-01
2021-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
NCT01365403
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
NCT01629368
A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants
NCT06005688
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers
NCT02253849
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood
NCT06028464
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AT-527 550 mg + carbamezepine
Period 1: AT-527 550 mg
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
Period 2: carbamazepine
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 + carbamazepine
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
AT-527 1100 mg + carbamezepine
Period 1: AT-527 550 mg
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
Period 2: carbamazepine
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 1100 mg + carbamazepine
AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Period 1: AT-527 550 mg
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
Period 2: carbamazepine
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 + carbamazepine
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 + carbamazepine
AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Atea Study Site
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AT-03A-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.