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| ID | Type | Description | Link |
|---|---|---|---|
| 1013148 | Registry Identifier | IRAS | |
| IRAS number- 1013148 | Other Identifier | Galmed Pharma |
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Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.
Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A- Administration of Aramchol Meglumine tablet | Experimental | 12 subjects will be randomized to Part A. Participants will receive Aramchol meglumine tablet (test formulation) at 2 different single doses and plasma concentration will be assessed. |
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| Part B- Administration of Aramchol meglumine or Aramchol acid tablets | Experimental | 20 subjects will be randomized to Part B. Participants will receive Aramchol meglumine once daily for 10 days based on a dose predicted in Part A. Steady-state plasma concentration of Aramchol will be assessed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aramchol | Drug | Aramchol tablet at 2 different single doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed peak concentration (Cmax) of Aramchol | Blood samples will be collected for pharmacokinetics characterization. Cmax will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | 2 months |
| Time to reach maximum concentration (Tmax) of Aramchol | Blood samples will be collected for pharmacokinetics characterization. Tmax will be calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics | 2 months |
| Area under the plasma curve (AUC) of Aramchol | Blood samples will be collected for pharmacokinetics characterization. AUC of Aramchol will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum observed concentration (Cmin) of Aramchol | Blood samples will be collected for pharmacokinetics characterization. Cmin will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | 2 months |
| Terminal elimination half life (T1/2) of Aramchol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yossi Gilgun-Sherki, PhD, MBA | Contact | 0543314054 | yossigs@galmedpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Christina Yeung, MBBS | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | Recruiting | London | NW10 7EW | United Kingdom |
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| ID | Term |
|---|---|
| C455117 | aramchol |
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Each participant will attend 2 trial sessions in a crossover design with a wash-out interval of at least 14 days between dosing in each session.
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This will be an open-label study
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Blood samples will be collected for pharmacokinetics characterization. T1/2 will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
| 2 months |
| Average observed concentration (Cavg) of Aramchol | Blood samples will be collected for pharmacokinetics characterization. Cavg will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. | 2 months |
| Safety and tolerability of Aramchol | The number of participants with treatment-related adverse events, as assessed by CTCAE v4.0 | 2 months |