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

NCT05154123 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-03A-012
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

AT-527 + rosuvastatin (simultaneous) n=14

EXPERIMENTAL

Drug: Drug: AT-527 + rosuvastatin

AT-527 + rosuvastatin (staggered) n=14

EXPERIMENTAL

Drug: AT-527 + rosuvastatin

Interventions

Drug: AT-527 + rosuvastatin DRUG

* Day 1: A single dose of rosuvastatin will be administered. * Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.

Also known as: AT-527 is also know as R07496998

AT-527 + rosuvastatin (simultaneous) n=14

AT-527 + rosuvastatin DRUG

* 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)

Also known as: AT-527 is also know as R07496998

AT-527 + rosuvastatin (staggered) n=14

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

Québec, Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

AT-511; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-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: November 16, 2021
• First Posted: December 10, 2021
• Study Start: November 16, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: February 25, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)