Recent Updates
Recently added Catalysts

Days 1-7 Bemnifosbuvir/Ruzasvir co-administered. Days 8-17 Bemnifosbuvir/Ruzasvir co-administered+ Biktarvy. Days 18-24 BIK

Phase 1

Healthy Volunteer Study | Small molecule | Other |Atea Pharmaceuticals, Inc.|Last Updated: Jul 31, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

FAST_TRACK

Clinical trial landscape

Days 1-7 Bemnifosbuvir/Ruzasvir co-administered. Days 8-17 Bemnifosbuvir/Ruzasvir co-administered+ Biktarvy. Days 18-24 BIK · 1 trial · 1 indication

Phase 1 1
NCT06356194Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/RuzasvirHealthy Volunteer Study
COMPLETED28 Analytics
PHASE1COMPLETED
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Healthy Volunteer Study
NCT0635619428
Unlock trial analytics

Study Endpoints

Primary Endpoints

PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR).
Day 2, Days 4-7, Days 14-17, Days 21-24

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

To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine)
Days 7-10, Day 12, Days 14-17, Days 21-24.

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

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BEM/RZR vs BEM/RZR + BIK vs BIKEXPERIMENTALn=14
BIK vs BEM/RZR + BIK vs BEM/RZREXPERIMENTALn=14

Interventions

NameTypeDescription
Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIKDRUGA co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)
Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered.DRUGA co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 18-30 kg/m2. * Willing to comply with the study requirements and to provide written in...

Countries:Canada
Unlock Eligibility Criteria