Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)
NCT ID: NCT00740610
Last Updated: 2014-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2008-08-31
2009-09-30
Brief Summary
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Detailed Description
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GS-9450 1mg by mouth (PO) once daily, GS-9450 5 mg PO once daily, GS-9450 10 mg PO once daily, GS-9450 40 mg PO once daily, or Matching placebo PO once daily Qualifying subjects will be stratified by the presence/absence of type 2 diabetes (i.e., on/off oral diabetic medication at entry) and by geographic region (US and France). Following randomization, subjects will return within five business days later for a baseline visit, at which time they will be dispensed study medication and enter a 4-week treatment phase. Upon completion of the treatment phase, subjects will enter a 4 week off-treatment follow-up period. Each subject's participation in the study will last up to approximately 12 weeks (inclusive of screening, treatment phase, and off-treatment follow-up period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
22 subjects to receive 1 mg GS-9450 for 4 weeks
GS-9450
GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
Cohort 2
22 subjects to receive 5 mg GS-9450 for 4 weeks
GS-9450
GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
Cohort 3
22 subjects to receive 10 mg GS-9450 for 4 weeks
GS-9450
GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
Cohort 4
22 subjects to receive 40 mg GS-9450 for 4 weeks
GS-9450
GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
Cohort 5
22 subjects to receive placebo to match GS-9450 for 4 weeks
GS-9450 Placebo
Placebo to match GS-9450 administered orally once daily
Interventions
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GS-9450
GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily
GS-9450 Placebo
Placebo to match GS-9450 administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* 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 \>/= 70 mL/min
* non-insulin dependent diabetes for \< 10 years is allowed if stably managed for at least 6 months prior to screening
* stable weight (no weight loss \> 4%) for 8 weeks prior to screening and should maintain consistent diet, food intake, and physical exercise during the study
* must have been on stable therapy for at least 3 months prior to screening if receiving 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors, niacin, fibrates, vitamin E or angiotensin receptor blockers
* must have been on a stable treatment regimen for at least 3 months prior to screening if receiving other drugs possibly associated with hepatic adverse events (e.g., isoniazid, itraconazole, ketoconazole, rifabutin, rifampin, and other agents with significant hepatotoxic potential)
Exclusion Criteria
* A \> 4% decrease in weight within 8 weeks of screening
* cirrhosis or decompensated liver disease (defined as conjugated bilirubin \> 1.5 x the upper limit of the normal range (ULN), prothrombin time \> 1.5 x ULN, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation
* presence of other form of liver disease other than NASH
* history of excess alcohol ingestion, averaging \> 3 drinks/day in the previous 2 years; or current alcohol intake averaging \> 2 drinks/day for females and \> 3 drinks per day for males; history of or current binge drinking
* serological evidence of co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
* evidence of hepatocellular carcinoma (i.e., α-fetoprotein \> 50 ng/mL)
* history of ingesting drugs possibly associated with hepatic steatosis within the past year
* history of total parenteral nutrition within the past 6 months
* prior history of gastroplasty, jejunoileal, or jejunocolonic bypass surgery
* history of ingesting drugs within the past 3 months that may improve NASH and associated fibrosis
* significant gastrointestinal disease that would interfere with absorption of oral medications; inflammatory bowel disease
* major surgery within the past year
* clinically significant abnormalities on ECG or other ECG findings that the investigator considers a safety risk
* significant systemic or major illnesses other than liver disease that, in the opinion of the investigator, would preclude treatment and adequate follow up
* prior or current malignancy involving any organ system and skin cancer (previously excised basal cell carcinoma allowed)
* acute ongoing infection, or symptoms of infection
* pregnant or breastfeeding females
* acute substance abuse within the past year.
* history of ingesting anti-TNFα drugs or immunomodulators within the past 3 months
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Elsa Mondou, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Tucson, Arizona, United States
Fresno, California, United States
Fullerton, California, United States
San Diego, California, United States
San Mateo, California, United States
Lakewood, Colorado, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Monroe, Louisiana, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
Troy, Michigan, United States
New York, New York, United States
Plainview, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Clevleand, Ohio, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Galveston, Texas, United States
Irving, Texas, United States
Charlottesville, Virginia, United States
Falls Church, Virginia, United States
Richmond, Virginia, United States
Paris, , France
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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GS-US-228-0101
Identifier Type: -
Identifier Source: org_study_id
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