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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: Period 1: AT-527 550 mg; Drug: Period 2: carbamazepine; Drug: Period 3: AT-527 550 mg + carbamazepine; Drug: Period 3: AT-527 1100 mg + carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AT-527 550 mg + carbamezepine	Drug: Period 1: AT-527 550 mg; 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; Drug: 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; Drug: 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; Other Names: AT-527 is also known as RO7496998
EXPERIMENTAL: AT-527 1100 mg + carbamezepine	Drug: Period 1: AT-527 550 mg; 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; Drug: 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; Drug: 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 Names: AT-527 is also known as RO7496998

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of AT-527 (RO7496998)	Maximum plasma concentration (Cmax)	Day 1 vs Day 26
Pharmacokinetics (PK) of AT-527 (RO7496998)	Area under the concentration-time curve (AUC)	Day 1 vs Day 26

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): April 10, 2021
• Study Completion (ACTUAL): April 10, 2021

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Carbamazepine
• Other Study ID Numbers: AT-03A-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No