| Trial ID: | L0689 |
| Source ID: | EUCTR2008-002361-31-FR
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| Associated Drug: |
GS-9450
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| Title: |
A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Activity of GS 9450 in Adults with Non-Alcoholic Steatohepatitis (NASH)
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-Alcoholic Steatohepatitis (NASH) <br>MedDRA version: 9.1
Level: LLT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
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| Interventions: |
<br>Product Name: N/A<br>Product Code: GS-9450<br>Pharmaceutical Form: Capsule*<br>CAS Number: 908253-63-4<br>Current Sponsor code: GS-9450<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1 -<br>Pharmaceutical
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| Outcome Measures: |
Main Objective: ?€? To investigate the safety and tolerability of multiple oral doses of GS 9450 in subjects with NASH;Secondary Objective: ?€? To investigate the pharmacokinetics of multiple oral doses of GS 9450 and its metabolites in subjects with NASH<br>?€? To investigate the activity of multiple oral doses of GS 9450 in subjects with NASH, as evidenced by: (1) change from baseline in CK 18 fragments, (2) change from baseline in ALT, and (3) change from baseline in other non-invasive biomarkers (including metabolic markers)<br>;Primary end point(s): Primary Endpoints<br><br>Safety Endpoints<br>The primary safety endpoint will evaluate the tolerability of multiple oral doses of<br>GS-9450. This endpoint will be assessed using treatment-limiting adverse events or<br>laboratory abnormalities that require premature discontinuation from the study.<br><br>Activity Endpoints<br>The primary activity endpoints are the following at Week 4:<br>?€? Change (absolute, percent) from baseline in CK-18 fragments, ALT, and AST levels;<br>Additionally, change from baseline in non-invasive markers (C-peptide, free fatty acids, adiponectin, IL-6, TNFa, FibroTest, high-sensitivity C- reactive protein) will be<br>evaluated.<br><br>The following endpoints, which may affect activity, will be evaluated at Week 4:<br>?€? change in body weight and BMI from baseline; and<br>?€? change in serum lipid profile from baseline.<br><br>Pharmacokinetic Endpoints<br>The primary pharmacokinetic endpoints of this study are to characterize the plasma<br>pharmacokinetic parameters of GS-9450 and metabolites following multiple doses of<br>GS-9450. The pharmacokinetic parameter endpoints to be evaluated are Week 2-4 Cmax, Tmax, Cmin, ?z, T1/2, AUCtau, Vdss/F (GS-9450 only) and CL/F (GS-9450 only).nan
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| Sponsor/Collaborators: |
Gilead Sciences Incorporated
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Not applicable
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| Enrollment: |
110
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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| Start Date: |
27/06/2008
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
28 August 2012
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| Locations: |
France
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002361-31
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