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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000385-30 | EudraCT Number |
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The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB0942 | Experimental | Cohort 1 (Japanese subjects): Single dose of UCB0942 (dosage regimen 1) Cohort 2 (Japanese subjects): Single dose of UCB0942 (dosage regimen 2) Cohort 3 (Japanese subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2) Cohort 4 (Caucasian subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2) |
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| Placebo | Placebo Comparator | Cohort 1 and Cohort 2: Single dose of Placebo Cohort 3 and Cohort 4: Single dose of Placebo followed, after maximum 21 days, by multiple doses of Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0942 | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: maximum observed plasma concentration of UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | |
| AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| Measure | Description | Time Frame |
|---|---|---|
| tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | |
| tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period |
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Inclusion Criteria:
Exclusion Criteria:
At screening:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0039 001 | London | United Kingdom |
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| Placebo |
| Other |
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| Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period | AUC is calculated as AUC(0-t)+Clast/kel, where Clast is the last observed quantifiable plasma concentration and kel is the apparent terminal elimination rate constant | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| Adverse events (AEs) reported spontaneously by the subject or observed by the investigator | From Screening until safety follow up visit (up to Week 18) |
| Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination | From Baseline until safety follow up visit (up to Week 18) |