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

A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Quebec
    • Québec, 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AT-527 + rosuvastatin (simultaneous) n=14	Drug: Drug: AT-527 + rosuvastatin; Day 1: A single dose of rosuvastatin will be administered.; Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.; Other Names: AT-527 is also know as R07496998
EXPERIMENTAL: AT-527 + rosuvastatin (staggered) n=14	Drug: AT-527 + rosuvastatin; Day 1: A single dose of rosuvastatin will be administered.; Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later); Other Names: AT-527 is also know as R07496998

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin	Maximum plasma concentration (Cmax)	Day 1, Day 8
To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin	Area under the concentration-time curve (AUC)	Day 1, Day 8
To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin	Area under the concentration-time curve (AUC)	Day 1, Day 8
To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin	Maximum plasma concentration (Cmax)	Day 1, Day 8

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2021
• Primary Completion (ACTUAL): December 23, 2021
• Study Completion (ACTUAL): December 23, 2021

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (ACTUAL): December 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: AT-03A-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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