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this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian subjects aged 18 to 55 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese group | Experimental | The subjects will receive in Period 1 either the low-dose or high-dose first, and in Period 2 they will receive the alternate dose. There is a washout period between periods. |
|
| non-Asian group | Experimental | The subjects will receive in Period 1 either the low-dose or high-dose first, and in Period 2 they will receive the alternate dose. There is a washout period between periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palovarotene low-dose | Drug | oral capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma drug concentration | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Time to reach maximum (peak) plasma concentration following drug administration | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Area under the plasma concentration time curve from time zero to the last quantifiable time point, calculated by linear-log trapezoidal summation | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Area under the plasma concentration time curve from time zero to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable plasma concentration divided by the elimination rate constant | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Terminal disposition rate constant/terminal rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Elimination half-life | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
| Apparent volume of distribution after non-intravenous (oral) administration | pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. | |
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Key Inclusion Criteria:
Non-Asian Subjects:
Japanese Subjects
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
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The subjects will be randomized to receive in Period 1 either the low-dose or high-dose first, and in Period 2 they received the alternate dose.
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| palovarotene high-dose |
| Drug |
oral capsules |
|
| Apparent total clearance of the drug from plasma after oral administration calculated by dose/ AUC(0-∞) |
| pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration. |
| ID | Term |
|---|---|
| C546535 | Palovarotene |
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