Clinical Trial Details
| Trial ID: | L0392 |
| Source ID: | ACTRN12621000255886 |
| Associated Drug: | GDD3898 |
| Title: | A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of GDD3898 Topical Gel in Healthy Volunteers |
| Acronym: | -- |
| Status: | Not Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic fatty liver disease ; <br>Nonalcoholic fatty liver disease ;Metabolic and Endocrine - Other metabolic disorders;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon |
| Interventions: | This is a single centre, double-blind, randomised, vehicle-controlled study to assess the safety, tolerability, and pharmacokinetics of GDD3898 Topical Gel 1.75% following twice daily application (approximately 12 hours apart) for 14 days in healthy volun |
| Outcome Measures: | To assess the safety of GDD3898 Topical Gel in healthy volunteers. Safety assessments include vital signs, physical examination, safety laboratory testing, ECG, and opthalmological assessments. <br><br>Ophthalmological assessments include visual acuity, eyelid examination, corneal staining, tear break-up time, and dry eye assessment.[Vitals signs will be collected at screening and daily from Admission (Day -1) to Discharge (Day 16)<br><br>Physical examinations will be collected at Screening, Admission, and Discharge.<br><br>Blood samples for safety laboratory testing will be collected at Screening, Admission, Day 14, and Discharge. <br><br>ECGs and ophthalmological assessments will be collected at Screening, Admission, and Discharge. ];To assess the tolerability of GDD3898 Topical Gel in healthy volunteers by local skin tolerability assessments by assessing the application site for local skin irritation.[The application site will be assessed for local skin irritation on Days 1, 7, and 14.]To evaluate the pharmacokinetic (PK) profile of GDD3898 Topical Gel and its major metabolite GDD3990. PK analysis will be performed for Cmax, AUClast, AUCinf, tmax, t??, AUC0-t, AUC0-24, and AUC. [Blood samples for PK analysis will be collected at: <br>Day 1, 7, and 14: Predose, 1, 2, 4, 6, 8, and 12 hours after the morning application <br>Day 2, 7, 15: 12 hrs after previous evening's application <br> ] |
| Sponsor/Collaborators: | Lipidio Pharmaceuticals Australia Pty Ltd. |
| Gender: | All |
| Age: | 18 Years65 Years |
| Phases: | Phase 1 |
| Enrollment: | 16 |
| Study Type: | Interventional |
| Study Designs: | Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety; |
| Start Date: | 10/03/2021 |
| Completion Date: | 28/03/2021 |
| Results First Posted: | 10/03/2021 |
| Last Update Posted: | 18 October 2021 |
| Locations: | Australia |
| URL: | https://anzctr.org.au/ACTRN12621000255886.aspx |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D530 | GDD3898 | Chemical drug | -- | -- | Hepatoprotectants; Obesity therapies | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D083 | CLA | Chemical drug | DB01211 | KCNH2; SLCO1B1; SLCO1B3 | -- | Under clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |
| D316 | S-adenosyl-L-methionine | Chemical drug | DB00118 | GNMT cofactor | Antiviral | Under clinical trials | Details |