Bronchopulmonary PK of AT-527 (R07496998) | NCT04877769

Studies
Bronchopulmonary PK of AT-527 (R07496998)

NCT04877769

Sponsor

Atea Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Feb 25, 2022Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Volunteer Study

Interventions

AT-527

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2021Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

May 4, 2021

First Submission Date that Met QC Criteria

May 4, 2021

First Posted Date

May 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2022

Last Update Posted Date

Feb 25, 2022Actual

Name	Class
Hoffmann-La Roche	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AT-527 Group A	Experimental	n=8	Drug: AT-527
AT-527 Group B	Experimental	n=8	Drug: AT-527
AT-527 Group C	Experimental	n=8	Drug: AT-527

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT-527	Drug	administered twice daily (BID) for 2.5 days (5 doses in total)	AT-527 Group A AT-527 Group B AT-527 Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of AT-527 in epithelial lining fluid		4-5 hours after last dose and 11-12 hours after last dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must agree to use birth control, as required by the protocol.
Females must have a negative pregnancy test at Screening and prior to dosing
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atea Study Site		London		NW10 7EW	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C000713067	AT-511

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided