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

NCT04784000 | Completed Phase 1

• 1 other identifier: AT-03A-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Period 1: AT-527 550 mg DRUG

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

AT-527 1100 mg + carbamezepine; AT-527 550 mg + carbamezepine

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

AT-527 1100 mg + carbamezepine; AT-527 550 mg + carbamezepine

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

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

AT-527 550 mg + carbamezepine

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

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

AT-527 1100 mg + carbamezepine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Atea Study Site

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

AT-511; Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2021
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

CA (1)