NCT05731843

Brief Summary

Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 30, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

February 9, 2023

Last Update Submit

May 31, 2023

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK) of BEM

    Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

    Days 6, 12, 18

  • Pharmacokinetics (PK) of Ruzasvir

    Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)

    Days 6, 12, 18

Study Arms (2)

BEM vs BEM + Ruzasvir n=16

EXPERIMENTAL
Drug: Cohort 1 BEM + Ruzasvir

Ruzasvir vs Ruzasvir + BEM n=16

EXPERIMENTAL
Drug: Cohort 2 Ruzasvir + BEM

Interventions

Cohort 1 BEM + RuzasvirDRUG

Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions

Also known as: AT-527
BEM vs BEM + Ruzasvir n=16
Cohort 2 Ruzasvir + BEMDRUG

Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions

Also known as: AT-527
Ruzasvir vs Ruzasvir + BEM n=16

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Québec, Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

ruzasvirAT-511

Study Design

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

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 16, 2023

Study Start

January 30, 2023

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

CA(1)