Clinical Trial Details
| Trial ID: | L0598 |
| Source ID: | ACTRN12615001355561 |
| Associated Drug: | DUR-928 |
| Title: | Dose Ranging, Single Dose Safety and Pharmacokinetic Study of DUR-928 in Subjects with Nonalcoholic Steatohepatitis (NASH) and Control Healthy Subjects |
| Acronym: | -- |
| Status: | Not Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Steatohepatitis (NASH); <br>Nonalcoholic Steatohepatitis (NASH);Metabolic and Endocrine - Other metabolic disorders;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon |
| Interventions: | DUR-928 powder for constitution.<br>Each dose of DUR-928 is given in 60 mL of ORA-Blend (registered trademark) SF taste masking suspending vehicle. The dose will be taken orally.<br>Each subject will receive a single dose of DUR-928 according to the Cohor |
| Outcome Measures: | To evaluate the safety of DUR-928 in subjects with NASH following single ascending dose at three dose level compared to healthy subjects control. [Routine vital sign measurements (temperature [T], blood pressure [BP], pulse and respiratory rate [RR]) will be measured at screening, check-in (Day -1), pre-dose, and 1, 2, 4, 6, 12, 24 and 48 hours post-dose and at trial completion. Physical examination will be performed at screening, check-in (Day -1), and at trial completion. The physical exam done on Day -1 will be abbreviated (including general appearance and evaluation of head, eyes, ears, nose, throat and neurological system). Safety Laboratory tests (Chemistry, Hematology, and Urinalysis) will be drawn at screening, check-in (Day -1), 24 and 48 hours post-dose, and on Day 7 (trial completion). Twelve-lead ECGs will be obtained from subjects at screening, check-in (Day -1), and at approximately 2, 4, 12 and 48 hours post-dose. Additional ECGs may be obtained if clinically indicated. Timepoint: AE collection starts from the time the subject checks in (Day -1) and continues through trial completion/early termination (Day 7). ];To evaluate the pharmacokinetics of DUR-928 in subjects with NASH following single ascending dose at three dose level compared to healthy subjects control. The pharmacokinetics of DUR-928 are evalutated using blood and urine samples. [Pharmacokinetic samples are collected at the following timepoints: pre-dose, and at 0.5, 1, 2, 4, 8, 12, 16, 24 and 48 hours post-dose. ]To evaluate the effects of DUR-928 selected biomarkers following a single dose.[The following biomarkers will be assessed using blood samples: <br>*High-sensitivity C-reactive protein (hs-CRP) <br>*HOMA- IR (insulin sensitivity) <br>*CK-18 fragments (cCK18, fCK18) <br>*Subset of cytokines (IL-1beta, IL6, IL12, IL-18 and TNFa) <br>*Lipid Panel (TG, HDL, LDL), Hepatic Enzyme Levels (AST, ALT), Total Bilirubin <br>Biomarker blood samples are collected at the following timepoints: Day -1, pre-dose , and at 1, 2, 4, 8, 12, 24 and 48 hours post-dose. <br>] |
| Sponsor/Collaborators: | INC Research |
| Gender: | All |
| Age: | 18 Years70 Years |
| Phases: | Phase 1 |
| Enrollment: | 32 |
| Study Type: | Interventional |
| Study Designs: | Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety; |
| Start Date: | 14/12/2015 |
| Completion Date: | -- |
| Results First Posted: | -- |
| Last Update Posted: | 13 January 2020 |
| Locations: | Australia |
| URL: | https://anzctr.org.au/ACTRN12615001355561.aspx |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D526 | DUR-928 | Chemical drug | -- | DNA methylation inhibitors; Inflammation mediator modulators; Lipid modulators | Anti-inflammatories; Antipsoriatics; Hepatoprotectants | Under clinical trials | Details |
| D082 | CK-18 | Miscellany | -- | -- | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D316 | S-adenosyl-L-methionine | Chemical drug | DB00118 | GNMT cofactor | Antiviral | Under clinical trials | Details |
| D545 | Pig placenta extract | Biological extract | -- | -- | -- | Under clinical trials | Details |