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

NCT ID: NCT04865445

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-05-15

Brief Summary

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

Conditions

Healthy Volunteer Study

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AT-527 550 mg + midazolam (simultaneous)

n=12

Group Type: EXPERIMENTAL

AT-527 550 mg + midazolam

Intervention Type: DRUG

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 mg + midazolam (staggered)

n=12

Group Type: EXPERIMENTAL

AT-527 550 mg + midazolam

Intervention Type: DRUG

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

Interventions

AT-527 550 mg + midazolam

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

Intervention Type: DRUG

AT-527 550 mg + midazolam

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atea Study Site

Montreal, Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

AT-03A-009

Identifier Type: -

Identifier Source: org_study_id