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OpenTrials
Completed

NCT Number: NCT04849299

Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)

This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects

Completed

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

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
  • 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

AT-527 550 mg + cyclosporine

Drug

550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998

Primary outcomes

  1. Pharmacokinetics (PK) of AT-527 (R07496998): Cmax

    Time frame: Day 1 vs Day 7

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527 (R07496998): AUC

    Time frame: Day 1 vs Day 7

    Area under the concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Aug 2, 2021

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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