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A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALG-055009 | Experimental | Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
|
| Placebo | Placebo Comparator | Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALG-055009 | Drug | Single or multiple doses of ALG-055009 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 14 days for Part 1 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 28 days for Part 2 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 35 days for Part 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Pharmacokinetic parameters of ALG-055009 in plasma | Predose (between -0.25 hours and 0 hours) up to 35 Days |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-055009 in plasma |
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Inclusion Criteria for Healthy Subjects:
Inclusion Criteria for Subjects with Mild Hyperlipidemia:
Exclusion Criteria for All Subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial | Rennes | France |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Drug |
Single or multiple doses of Placebo |
|
| Predose (between -0.25 hours and 0 hours) up to 35 Days |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-055009 in plasma | Predose (between -0.25 hours and 0 hours) up to 35 Days |
| Half-life [t1/2] | Pharmacokinetic parameters of ALG-055009 in plasma | Predose (between -0.25 hours and 0 hours) up to 35 Days |
| Minimum Plasma Concentration [Cmin] | Pharmacokinetic parameters of ALG-055009 in plasma | Predose (between -0.25 hours and 0 hours) up to 35 Days |
| Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia | Screening, Day -1 to Day 28 |