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

Study Overview
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Brief Summary
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Drug-drug interaction study of midazolam and AT-527 (R07496998)

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

Conditions
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Healthy Volunteer Study

Intervention / Treatment
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* Drug: AT-527 550 mg + midazolam
* Drug: AT-527 550 mg + midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 550 mg + midazolam (simultaneous)<br>n=12 | Drug: AT-527 550 mg + midazolam<br>* 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<br>|
| Experimental: AT-527 mg + midazolam (staggered)<br>n=12 | Drug: AT-527 550 mg + midazolam<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of midazolam | Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC) | Day 1, Day 3, Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 | Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC) | Day 3, Day 7 |