Drug-drug Interaction Study of Midazolam and AT-527 (R07496998)

Phase 1CompletedNCT04865445

Atea Pharmaceuticals, Inc.24 enrolled

Overview

Drug-drug interaction study of midazolam and AT-527 (R07496998)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

AT-527 550 mg + midazolamDRUG

Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Other Names: AT-527 is also know as R07496998

AT-527 550 mg + midazolamDRUG

Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening. Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening. Other Names: AT-527 is also know as R07496998

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2 * Abuse of alcohol or drugs * Use of other investigational drugs within 28 days of dosing * Concomitant use of prescription medications, or systemic over-the-counter medications * Other clinically significant medical conditions or laboratory abnormalities

Locations (1)

Atea Study Site

Montreal, Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of midazolam

Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)

Time frame: Day 1, Day 3, Day 7

Secondary Outcomes

Pharmacokinetics (PK) of AT-527

Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)

Time frame: Day 3, Day 7

Data from ClinicalTrials.gov

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