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atazanavir

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

atazanavir · 1 trial · 1 indication

Phase 1 1
NCT01592305A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or AtazanavirHealthy Volunteer
COMPLETED40 Analytics
PHASE1COMPLETED
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
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Study Endpoints

Primary Endpoints

Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC)
Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20
Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC)
Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20

Secondary Endpoints

Safety: Incidence of adverse events
approximately 2 months
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Study Design & Arms

MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
S1 P1 TDF + DNV/rEXPERIMENTAL -
S1/S2 P2 DNV/r + ATZEXPERIMENTAL -
S2 P1 ATZ/rEXPERIMENTAL -

Interventions

NameTypeDescription
atazanavirDRUGmultiple oral doses
danoprevirDRUGmultiple oral doses
ritonavirDRUGmultiple oral doses
tenofovir disoproxil fumarateDRUGsingle oral doses
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female volunteers, 18 to 55 years of age, inclusive * Body weight \>/= 55 kg * Body mass index (BMI) 18.0 - 32.0 kg/m2 * Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical a...

Countries:United States
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Frequently asked questions about atazanavir

What is atazanavir?

Atazanavir is a small molecule drug being studied in a Phase 1 clinical trial. It is being investigated in healthy volunteers as part of a drug-drug interaction study. The drug is being developed by Roche Holding AG.

What is atazanavir used for?

Atazanavir is being studied for use in healthy volunteers in a clinical trial context. The specific trial is a drug-drug interaction study, but the drug itself is not being developed for a particular disease indication in this study.

Who makes atazanavir?

Atazanavir is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial involving this drug.

What phase is atazanavir in?

Atazanavir is in Phase 1 clinical development. It has one completed trial with 40 participants enrolled. The drug is investigational and has not been approved for any use.

What clinical trials is atazanavir in?

Atazanavir has one completed Phase 1 clinical trial, identified as NCT01592305. This study examined drug-drug interactions between danoprevir coadministered with low-dose ritonavir and tenofovir disoproxil fumarate or atazanavir. The trial was conducted in the United States with 40 healthy volunteers.