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This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 10 Japanese and 8 Caucasian subjects. 8 out of 10 Japanese subjects will receive BLU-5937 Dose A and 2 will receive placebo. All Caucasian subjects will receive BLU-5937 Dose A. |
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| Cohort 2 | Experimental | 8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo. |
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| Cohort 3 | Experimental | 8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 | Drug | Single and multiple doses assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of ECG QTcF interval (ms) change | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Assessment of diastolic and systolic blood pressure (mmHg) change | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Assessment of heart rate (BPM) change | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Number of participants with clinically significant changes in Clinical laboratory tests | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Number of participants with clinically significant changes in Physical Examination | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Adverse Event and Adverse Event of medical interest monitoring | Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge) | |
| Measurement of the area under the plasma concentration by time curve (AUC) | Pre-dose up to 48 hours post-dose for both single and multiple administration | |
| Measurement of the maximum observed plasma drug concentration (Cmax) | Pre-dose up to 48 hours post-dose for both single and multiple administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd. | London | SE1 1YR | United Kingdom |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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