Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aramchol meglumine · 1 trial · 1 indication
Observed maximal concentration after administration
Area under the concentration/time curve to the last measurable concentration, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t
Area under the concentration/time curve, from time 0 h extrapolated to infinity
| Arm | Type | Description |
|---|---|---|
| Subjects receiving a single 400 mg dose of Aramchol meglumine in Period 1 | EXPERIMENTAL | A single 400 mg dose of Aramchol meglumine will be administered to all study subjects in Period 1. |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2 | ACTIVE_COMPARATOR | In Period 2, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3 | ACTIVE_COMPARATOR | In Period 3, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) |
| Name | Type | Description |
|---|---|---|
| Aramchol meglumine | DRUG | Aramchol meglumine is a salt form of Aramchol free acid |
| Aramchol free acid | DRUG | Aramchol free acid is a fatty acid-bile acid conjugate |
Inclusion Criteria: 1. Male or female subjects 2. Age between 18 and 45 years (inclusive of the date of signing the informed consent form) 3. Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and up to the s...
Aramchol meglumine is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial comparing its pharmacokinetics to Aramchol free acid tablets. It has not been approved for any indication.
Aramchol meglumine is being developed by Galmed Pharmaceuticals Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GLMD. The company is conducting clinical trials to evaluate the drug's pharmacokinetic profile in healthy subjects.
Aramchol meglumine is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved. It has received a Breakthrough Therapy designation from the FDA, though it remains investigational.
Aramchol meglumine has one completed clinical trial, NCT06502561, titled 'Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets.' This Phase 1 study enrolled 16 healthy volunteers in Bulgaria and was active-controlled, though not double-blinded.
Aramchol meglumine is a salt form of Aramchol, the free acid. The completed trial specifically compared the pharmacokinetics of Aramchol meglumine granules to Aramchol free acid tablets, indicating they are distinct formulations of the same active moiety.