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BMS-824393

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

BMS-824393 · 1 trial · 1 indication

Phase 1 1
NCT00971308Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C VirusChronic Hepatitis C
COMPLETED37 Analytics
PHASE1COMPLETED
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
Chronic Hepatitis C
NCT0097130837
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Study Endpoints

Primary Endpoints

Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Secondary Endpoints

To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess the safety and tolerability of multiple oral doses of BMS-824393
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-824393 (Panel 1)EXPERIMENTAL -
BMS-824393 (Panel 2)EXPERIMENTAL -
BMS-824393 (Panel 3)EXPERIMENTAL -
BMS-824393 (Panel 4)EXPERIMENTAL -
BMS-824393 (Panel 5)EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-824393DRUGCapsule, Oral, 50mg, Once Daily, 3 days
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1 * HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL) * Body Mass Index (BMI) of 18 to 35 kg/m², inclusive Exclusion Criteria: * Women who are pregnant or breast feeding * Any significant acute ...

Countries:United States
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Frequently asked questions about BMS-824393

What is BMS-824393 used for?

BMS-824393 is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is intended for patients with this viral infection, and it has been studied in a clinical trial setting to evaluate its effects.

Who makes BMS-824393?

BMS-824393 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational drug for chronic Hepatitis C.

What phase is BMS-824393 in?

BMS-824393 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing early-stage clinical trials to assess its safety and tolerability in patients with chronic Hepatitis C.

What clinical trials is BMS-824393 in?

BMS-824393 has been studied in one completed Phase 1 clinical trial, identified as NCT00971308. This trial was a multiple dose study conducted in the United States, enrolling 37 treatment-naive subjects infected with Hepatitis C virus. The trial was controlled but not randomized or double-blind.

Is BMS-824393 the same as any other drug?

No alternative names for BMS-824393 have been reported. The drug is known by its development code, BMS-824393, and is being investigated by Bristol-Myers Squibb for chronic Hepatitis C.