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This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanifibranor 800 mg | Experimental | In Part A, lanifibranor 800 mg is given as a single dose (followed by 14 days follow-up). In Part B, lanifibranor 800 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). |
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| Lanifibranor 120 mg | Experimental | In Part A, lanifibranor 1200 mg is given as a single dose (followed by 14 days follow-up). In Part B, lanifibranor 1200 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanifibranor | Drug | Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | Maximum plasma drug concentration | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Area under the plasma concentration-time curve | The area enclosed by the blood concentration curve to the timeline | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Time to maximum concentration (Tmax) | The time required to reach peak concentration after administration | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Apparent volume of distribution (Vd/F) | Drug dose reach a dynamic balance in the body the body and blood drug concentration ratio constant | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Apparent plasma clearance (CL/F) | The volume of plasma with drug cleared per unit of time | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Plasma elimination half-life (t1/2) | The time it takes for the terminal phase blood concentration to drop by half | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Time to maximum concentration at steady state (Tmax, ss) in Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The occurrence rate of all adverse events (AEs), and adverse events of special interest (AESI) and serious adverse events (SAEs). | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Adverse event rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| C000619516 | lanifibranor |
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The time required to reach peak steady-state concentration after administration
| Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Maximum concentration at steady state (Cmax, ss) in Part B | The maximum blood drug concentration that occurs after stabilization | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Minimum concentration at steady state (Cmin, ss) in Part B | The minimum blood drug concentration that occurs after stabilization | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
| Average steady-state plasma concentration (Cav, ss) in Part B | The plasma concentration at which the rate of administration and rate of elimination are in equilibrium. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |
The occurrence rate of abnormal clinical laboratory tests, vital signs, physical examination and 12 lead-electrocardiogram (ECG). |
| Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose. |