Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06502561 | Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets | PHASE1 | COMPLETED | 16 | — | — | Feb 15, 2025 | Nov 17, 2025 | Jun 1, 2026 | 1 | Bulgaria |
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...