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Completed

NCT Number: NCT05154123

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

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

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Québec, Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: AT-527 is also know as R07496998

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)

Other names: AT-527 is also know as R07496998

Primary outcomes

  1. To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin

    Time frame: Day 1, Day 8

    Maximum plasma concentration (Cmax)

  2. To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin

    Time frame: Day 1, Day 8

    Area under the concentration-time curve (AUC)

  3. To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin

    Time frame: Day 1, Day 8

    Area under the concentration-time curve (AUC)

  4. To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin

    Time frame: Day 1, Day 8

    Maximum plasma concentration (Cmax)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2021
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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