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This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Part 2 will also include an evaluation of the effect of multiple doses of BLU-808 on the single-dose pharmacokinetics (PK) of midazolam. Part 3 is an open-label, 2-sequence, 2-period, food effect (FE) study in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BLU-808 | Experimental | BLU-808 will be administered orally. |
|
| Part 1: Placebo | Placebo Comparator | Matching placebo for BLU-808 will be administered orally. |
|
| Part 2: BLU-808 | Experimental | BLU-808 will be administered orally. |
|
| Part 2: Placebo | Placebo Comparator | Matching placebo for BLU-808 will be administered orally. |
|
| Part 2: Midazolam Alone Followed by BLU-808 and Midazolam | Experimental | Participants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2. |
|
| Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-808 | Drug | BLU-808 will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 20 | |
| Part 2: Number of Participants With TEAEs | Up to Day 50 | |
| Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t) | Up to Day 6 | |
| Part 3: Maximum Observed Plasma Concentration (Cmax) | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: AUC0-t | Up to Day 6 | |
| Part 1: Cmax | Up to Day 6 | |
| Part 1: Terminal Elimination Half-life (t1/2) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-specified inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Parts 1 and 2 are double-blind and placebo-controlled. Part 3 is open-label.
Participants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2.
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| Part 3: BLU-808 (Treatment D, E) | Experimental | BLU-808 will be administered orally. |
|
| Part 3: BLU-808 (Treatment E, D) | Experimental | BLU-808 will be administered orally. |
|
| Placebo | Drug | BLU-808 matching placebo will be administered per schedule specified in the arm description. |
|
| Midazolam | Drug | Midazolam will be administered per schedule specified in the arm description. |
|
| Up to Day 6 |
| Part 1: Change From Baseline in QTc (Corrected Value of the Interval Between the Q and T Waves on the Electrocardiogram Tracing) | Up to Day 6 |
| Parts 1 and 2: Change From Baseline in Serum Tryptase Concentrations | Up to Day 6 |
| Part 2: AUC0-t | Up to Day 14 |
| Part 2: Cmax | Up to Day 14 |
| Part 2: t1/2 | Up to Day 19 |
| Part 3: Number of Participants With TEAEs | Up to Day 26 |
| D006571 | Heterocyclic Compounds |