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

July 27, 2021 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AT-527 550 mg + cyclosporine (simultaneous)
n=12
Drug: AT-527 550 mg + cyclosporine
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
Drug: AT-527 550 mg + cyclosporine
550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998
EXPERIMENTAL: AT-527 550 mg + cyclosporine (staggered)
n=12
Drug: AT-527 550 mg + cyclosporine
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
Drug: AT-527 550 mg + cyclosporine
550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of AT-527 (R07496998): Cmax
Time Frame: Day 1 vs Day 7
Maximum plasma concentration (Cmax)
Day 1 vs Day 7
Pharmacokinetics (PK) of AT-527 (R07496998): AUC
Time Frame: Day 1 vs Day 7
Area under the concentration-time curve (AUC)
Day 1 vs Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Collaborators

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2021

Primary Completion (ACTUAL)

May 10, 2021

Study Completion (ACTUAL)

May 10, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 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

Other Study ID Numbers

  • AT-03A-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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