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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: AT-527 550 mg + midazolam; Drug: AT-527 550 mg + midazolam

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Quebec
    • Montreal, Montreal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT-527 550 mg + midazolam (simultaneous); n=12	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; 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
Experimental: AT-527 mg + midazolam (staggered); n=12	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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: AT-03A-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes