The Study of Bemnifosbuvir in Healthy Japanese Subjects | NCT05905497

Studies
The Study of Bemnifosbuvir in Healthy Japanese Subjects

NCT05905497

Sponsor

Atea Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Jun 15, 2023Actual

Enrollment

14Actual

Phase

Phase 1

Conditions

Healthy Volunteer Study

Interventions

Bemnifosbuvir (BEM)

Countries

United States

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

Jun 2023

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 26, 2023Actual

Primary Completion Date

May 19, 2023Actual

Completion Date

May 19, 2023Actual

First Submitted Date

Apr 20, 2023

First Submission Date that Met QC Criteria

Jun 14, 2023

First Posted Date

Jun 15, 2023Actual

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

Jun 14, 2023

Last Update Posted Date

Jun 15, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects

Detailed Description

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bemnifosbuvir (BEM)	Experimental	oral tablet	Drug: Bemnifosbuvir (BEM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bemnifosbuvir (BEM)	Drug	BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)	Bemnifosbuvir (BEM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)		Day 1, Day 5
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)		Day 1, Day 5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
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 18-32 kg/m2
Willing to comply with the study requirements and to provide written informed consent
The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
The subject must have lived outside of Japan for no more than 10 years

Exclusion Criteria:

Pregnant or breastfeeding
Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
Abuse of alcohol or drugs
Use of other investigational drugs within 28 days of dosing
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

64 Years

Standard Ages

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		Cypress	California	90630	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000713067	AT-511

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided