Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending doses with BLU-782 | Experimental |
| |
| Single ascending doses with placebo | Placebo Comparator |
| |
| Multiple ascending doses with BLU-782 | Experimental |
| |
| Multiple ascending doses with placebo | Placebo Comparator |
| |
| Food effect of BLU-782 taken with food | Experimental |
| |
| Food effect of BLU-782 taken without food | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-782 | Drug | oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782. | Baseline to Day 8 | |
| Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 . | Baseline to Day 17 | |
| Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food. | Baseline to Day 20 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Undisclosed | Lincoln | Nebraska | 68502 | United States |
Not provided
| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | oral capsules |
|
| BLU-782 taken with food | Drug | oral capsules |
|