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GS-9450

Phase 2

HCV Infection | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Trials Updated: Jun 19, 2014

GS-9450 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment157

FDA Designations

No designations recorded

GS-9450 clinical trials

GS-9450 · 2 trials · 2 indications

Phase 2 2
NCT00740610Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)Nonalcoholic Steatohepatitis
COMPLETED124 Analytics
NCT00725803Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCVHCV Infection
COMPLETED33 Analytics
PHASE2COMPLETED
Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)
Nonalcoholic SteatohepatitisUnlock trial analytics
PHASE2COMPLETED
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Baseline to Post-treatment Week 24
Safety and Tolerability
Throughout 7 weeks (2 weeks on treatment and 5 weeks post-treatment)

Secondary Endpoints

Pharmacokinetics of GS-9450 and its metabolites
Weeks 2 and 4
Change from baseline in alanine aminotransferase (ALT)
Baseline to Week 4
Plasma pharmacokinetic parameters of GS-9450 and metabolites
17 days (through 72 hours after last dose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL22 subjects to receive 1 mg GS-9450 for 4 weeks
Cohort 2EXPERIMENTAL22 subjects to receive 5 mg GS-9450 for 4 weeks
Cohort 3EXPERIMENTAL22 subjects to receive 10 mg GS-9450 for 4 weeks
Cohort 4EXPERIMENTAL22 subjects to receive 40 mg GS-9450 for 4 weeks
Cohort 5PLACEBO_COMPARATOR22 subjects to receive placebo to match GS-9450 for 4 weeks

Interventions

NameTypeDescription
GS-9450DRUGGS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
GS-9450 PlaceboDRUGPlacebo to match GS-9450 administered orally once daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * 18-75 years of age * ALT \> 60 U/L * fatty liver on screening ultrasound * and biopsy-confirmed NASH * platelet count \>/= 75,000/mm3 and adequate hematologic function (absolute neutrophil count \>/= 1,500/mm3, hemoglobin \>/= 11.0 g/dL) * calculated creatinine clearance \>/= ...

Countries:United StatesFranceGermanyNetherlands
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Frequently asked questions about GS-9450

What is GS-9450 used for?

GS-9450 is an investigational small molecule being studied for the treatment of Nonalcoholic Steatohepatitis (NASH) and HCV Infection. It is being developed by Gilead Sciences, Inc. (GILD). The drug is currently in Phase 2 clinical development, with completed trials in both indications.

What does GS-9450 target?

GS-9450 is a small molecule developed by Gilead Sciences, Inc. (GILD). Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential in treating Nonalcoholic Steatohepatitis (NASH) and HCV Infection, but the exact mechanism of action is not publicly detailed.

Who makes GS-9450?

GS-9450 is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is an investigational small molecule in Phase 2 clinical development for Nonalcoholic Steatohepatitis (NASH) and HCV Infection.

What phase is GS-9450 in?

GS-9450 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in HCV Infection and one in Nonalcoholic Steatohepatitis (NASH). The drug is not FDA approved and remains investigational, with no active trials currently listed.

What clinical trials is GS-9450 in?

GS-9450 has completed two Phase 2 clinical trials. The first, NCT00725803, evaluated safety and activity in 33 subjects with chronic HCV in the United States, Germany, and Netherlands. The second, NCT00740610, studied 124 adults with Nonalcoholic Steatohepatitis (NASH) in the United States and France. Both trials are completed.

Is GS-9450 the same as other drugs?

GS-9450 is an investigational small molecule developed by Gilead Sciences, Inc. (GILD). No alternative names for GS-9450 have been disclosed in available information. It is being studied for Nonalcoholic Steatohepatitis (NASH) and HCV Infection, but it is not known to be identical to any other marketed drug.