Recent Updates
Recently added Catalysts

PPI-461

Phase 1

Chronic Genotype 1 Hepatitis C Virus Infection | Small molecule | Infectious Disease |BioCryst Pharmaceuticals, Inc.|Last Updated: Feb 3, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

PPI-461 · 1 trial · 1 indication

Phase 1 1
NCT01247194A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1Chronic Genotype 1 Hepatitis C Virus Infection
COMPLETED24 Analytics
PHASE1COMPLETED
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
Chronic Genotype 1 Hepatitis C Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability, as measured by clinical adverse events and laboratory assessments
up to Study Day 16 (14 days after the last PPI-461 dose)
Antiviral effects of PPI-461, as measured by HCV RNA levels
Up to Study Day 16 (14 days after the last PPI-461 dose)
PPI-461 pharmacokinetics as measured by plasma PPI-461 concentrations
Up to Study Day 10 (8 days after the last PPI-461 dose)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AACTIVE_COMPARATORPPI-461 50 mg or placebo
Cohort BACTIVE_COMPARATORPPI-461 100 mg or placebo
Cohort CACTIVE_COMPARATORPPI-461 200 mg or placebo

Interventions

NameTypeDescription
PPI-461DRUGcapsule, oral, once daily for 3 days
PlaceboDRUGcapsules, oral, once daily for 3 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Eligibility Criteria: * Male or female, between 18 and 65 years of age (female patients must be surgically sterile or 2 years post-menopausal and are required to take a pregnancy test) * Body Mass Index (BMI) 18 - 32 kg/m2 * Chronically infected with hepatitis C genotype-1 virus * Serum HCV RNA \> ...

Countries:United StatesDenmarkUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about PPI-461

What is PPI-461 used for?

PPI-461 is an investigational small molecule being developed for the treatment of chronic genotype 1 hepatitis C virus infection. It is a Phase 1 drug candidate that has completed a clinical trial in patients with this condition.

Who makes PPI-461?

PPI-461 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX. The company is conducting clinical research on this investigational drug for chronic genotype 1 hepatitis C virus infection.

What phase is PPI-461 in?

PPI-461 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for the treatment of chronic genotype 1 hepatitis C virus infection.

What clinical trials is PPI-461 in?

PPI-461 has been studied in one completed Phase 1 clinical trial, identified as NCT01247194, titled "A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1." This trial enrolled 24 patients and was conducted in the United States, Denmark, and the United Kingdom.

Is PPI-461 the same as any other drug?

PPI-461 is the investigational name for this drug candidate developed by BioCryst Pharmaceuticals. No alternative names have been reported for this compound in the available clinical trial information.