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

Sponsor

Atea Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04849299

Collaborator

Hoffmann-La Roche (Industry)

Enrollment

Location

Arms

Actual Duration (Days)

33.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Study	Drug: AT-527 550 mg + cyclosporine Drug: AT-527 550 mg + cyclosporine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 18, 2021

Actual Primary Completion Date :

May 10, 2021

Actual Study Completion Date :

May 10, 2021

Arms and Interventions

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
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 on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998

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

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 on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK) of AT-527 (R07496998): Cmax [Day 1 vs Day 7]
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527 (R07496998): AUC [Day 1 vs Day 7]
Area under the concentration-time curve (AUC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atea Study Site	Montreal	Quebec	Canada

Sponsors and Collaborators

Atea Pharmaceuticals, Inc.
Hoffmann-La Roche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Atea Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04849299

Other Study ID Numbers:

AT-03A-005

First Posted:

Apr 19, 2021

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cyclosporine

Cyclosporins

Study Results

No Results Posted as of Aug 2, 2021