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Completed

NCT Number: NCT04784000

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

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

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Period 1: AT-527 550 mg

Drug

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

Other names: AT-527 is also known as RO7496998

Period 2: carbamazepine

Drug

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

Drug

AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26

Other names: AT-527 is also known as RO7496998

Period 3: AT-527 1100 mg + carbamazepine

Drug

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 names: AT-527 is also known as RO7496998

Primary outcomes

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

    Time frame: Day 1 vs Day 26

    Maximum plasma concentration (Cmax)

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

    Time frame: Day 1 vs Day 26

    Area under the concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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