NCT04849299

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

April 18, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

22 days

First QC Date

April 14, 2021

Last Update Submit

July 27, 2021

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK) of AT-527 (R07496998): Cmax

    Maximum plasma concentration (Cmax)

    Day 1 vs Day 7

  • Pharmacokinetics (PK) of AT-527 (R07496998): AUC

    Area under the concentration-time curve (AUC)

    Day 1 vs Day 7

Study Arms (2)

AT-527 550 mg + cyclosporine (simultaneous)

EXPERIMENTAL

n=12

Drug: AT-527 550 mg + cyclosporine

AT-527 550 mg + cyclosporine (staggered)

EXPERIMENTAL

n=12

Drug: AT-527 550 mg + cyclosporine

Interventions

AT-527 550 mg + cyclosporineDRUG

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 (simultaneous)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy adult male subjects
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

AT-511Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 19, 2021

Study Start

April 18, 2021

Primary Completion

May 10, 2021

Study Completion

May 10, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

CA(1)