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

Healthy Volunteer Study Clinical Trial

Official title:

A Phase 1 Open-Label Study to Evaluate the Interaction Potential Between AT 527 and Midazolam in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865445
• Other study ID #: AT-03A-009
• Status: Completed
• Phase: Phase 1
• Start date: April 22, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: July 2021
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Canada	Atea Study Site	Montreal	Montreal, Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of midazolam	Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)	Day 1, Day 3, Day 7
Secondary	Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC)	Day 3, Day 7