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CompletedNCT04784000Updated Jul 29, 2021

Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527

A Phase 1 interventional study of Period 1: AT-527 550 mg and Period 2: carbamazepine in Healthy Volunteer Study, sponsored by Atea Pharmaceuticals, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Atea Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.

02

Conditions studied

  • Healthy Volunteer Study
03

In context

Lead sponsor

Atea Pharmaceuticals, Inc. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    AT-527 550 mg + carbamezepine

    Drug: Period 1: AT-527 550 mg · Drug: Period 2: carbamazepine · Drug: Period 3: AT-527 550 mg + carbamazepine

  • Experimental
    AT-527 1100 mg + carbamezepine

    Drug: Period 1: AT-527 550 mg · Drug: Period 2: carbamazepine · Drug: Period 3: AT-527 1100 mg + carbamazepine

Interventions

  • DrugPeriod 1: AT-527 550 mg

    AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1

    Also known as: AT-527 is also known as RO7496998

  • DrugPeriod 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

  • DrugPeriod 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

    Also known as: AT-527 is also known as RO7496998

  • DrugPeriod 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

    Also known as: AT-527 is also known as RO7496998

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK) of AT-527 (RO7496998)

    Maximum plasma concentration (Cmax)

    Time frame: Day 1 vs Day 26

  2. Pharmacokinetics (PK) of AT-527 (RO7496998)

    Area under the concentration-time curve (AUC)

    Time frame: Day 1 vs Day 26

07

Study locations

1 site
  • Atea Study Site
    Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04784000
Lead sponsor
Atea Pharmaceuticals, Inc.
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Mar 5, 2021
Start date
Mar 1, 2021
Primary completion
Apr 10, 2021
Completion
Apr 10, 2021
Last update
Jul 29, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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