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NCT04849299 Clinical Trial

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

Healthy Volunteer Study Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04849299
Other study ID # AT-03A-005
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 18, 2021
Est. completion date May 10, 2021

Study information
Verified date July 2021
Source Atea Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date May 10, 2021
Est. primary completion date May 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Canada Atea Study Site Montreal Quebec

Sponsors (2)
Lead Sponsor Collaborator
Atea Pharmaceuticals, Inc. Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

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