Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aramchol free acid, single dose · 1 trial · 1 indication
AUC from time 0 to the dosing interval tau measured at steady state. Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Maximum plasma concentrations (Cmax,ss) Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
CL/F measured after single dose in Part 1 Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
| Arm | Type | Description |
|---|---|---|
| Part 1: Mild Hepatic Impairment (Cohort A) | EXPERIMENTAL | 8 mild hepatic impaired subjects |
| Part 1: Moderate Hepatic Impairment (Cohort B) | EXPERIMENTAL | 8 moderate hepatic impaired subjects |
| Part 1: Severe Hepatic Impairment (Cohort C) | EXPERIMENTAL | 8 severe hepatic impaired subjects |
| Part 1: Healthy Volunteers (Cohort D) | EXPERIMENTAL | 15 matched healthy volunteers |
| Part 2: Mild Hepatic Impairment Cohort | EXPERIMENTAL | 4 mild hepatic impaired subjects |
| Part 2: Moderate Hepatic Impairment Cohort | EXPERIMENTAL | 7 moderate hepatic impaired subjects |
| Part 2: Healthy Volunteers Cohort | EXPERIMENTAL | 7 matched healthy volunteers |
| Name | Type | Description |
|---|---|---|
| Aramchol free acid tablet 600mg, single dose | DRUG | Aramchol free acid tablet 600mg, single dose |
| Aramchol free acid tablet 300mg, bid | DRUG | Aramchol acid tablet 300mg, bid for 12 days |
Inclusion Criteria: 1. The subject is male or female 18 to 79 years of age, inclusive. 2. The subject has a body mass index of 19 to 40 kg/m2, inclusive, at screening. 3. Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1...
Aramchol free acid, single dose is an investigational small molecule being studied for hepatic impairment. It is being developed by Galmed Pharmaceuticals Ltd. (GLMD) and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this condition.
The molecular target of Aramchol free acid, single dose has not been disclosed in available information. The drug is a small molecule being evaluated for hepatic impairment, but its specific mechanism of action is not publicly detailed.
Aramchol free acid, single dose is being developed by Galmed Pharmaceuticals Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker GLMD. The company is conducting clinical research on this investigational drug for hepatic impairment.
Aramchol free acid, single dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for hepatic impairment, with one completed Phase 1 trial.
Aramchol free acid, single dose has one completed clinical trial, NCT04480827, an open-label study evaluating safety, tolerability, and pharmacokinetics in subjects with hepatic impairment. The trial enrolled 57 participants in the United States and included healthy volunteers.
Aramchol free acid, single dose is a specific formulation or dosing regimen of the drug Aramchol. While the name indicates a single-dose administration of the free acid form, the relationship to other Aramchol products is not fully detailed in available information.