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

NCT04865445 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-03A-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK) of midazolam

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

  Day 1, Day 3, Day 7

Secondary Outcomes (1)

• Pharmacokinetics (PK) of AT-527

  Day 3, Day 7

Study Arms (2)

AT-527 550 mg + midazolam (simultaneous)

EXPERIMENTAL

n=12

Drug: AT-527 550 mg + midazolam

AT-527 mg + midazolam (staggered)

EXPERIMENTAL

n=12

Drug: AT-527 550 mg + midazolam

Interventions

AT-527 550 mg + midazolam 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-527 550 mg + midazolam (simultaneous)

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:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Atea Study Site

Montreal, Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

AT-511; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: April 22, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

CA (1)