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| Name | Class |
|---|---|
| Denali Therapeutics Inc. | INDUSTRY |
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This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB122 (DNL151) | Drug | Oral doses |
| |
| [14C] BIIB122 ([14C] DNL151) |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration | 1 day | |
| PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration | 1 day | |
| PK Parameter: Area under the concentration-time curve (AUC) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 in plasma following oral and intravenous administration | 1 day | |
| PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151 has been eliminated (t1/2) in plasma after oral and intravenous administration | 1 day | |
| PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration | 1 day | |
| PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration | 1 day | |
| PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration | 1 day | |
| PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administration | 21 days | |
| PK Parameter: Maximum observed concentration (Cmax) of BIIB122 (DNL151) in plasma following oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | 31 days | |
| Incidence of serious adverse events (SAEs) | 31 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Denali Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C000730636 | DNL151 |
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| Drug |
Intravenous doses |
|
| 21 days |
| PK Parameter: Concentration of BIIB122 (DNL151) in plasma at the end of dosing interval | 21 days |
| PK Parameter: Area under the concentration-time curve of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) in plasma following oral and intravenous administration | 21 days |
| PK Parameter: Time from baseline at which half of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) has been eliminated (t1/2) in plasma after oral and intravenous administration | 21 days |
| PK Parameter: Volume of distribution (Vd/F and Vd) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration | 21 days |
| PK Parameter: Clearance (CL/F and CL) of BIIB122 (DNL151) and [14C]-BIIB122 ([14C]-DNL151) from plasma after oral and intravenous administration | 21 days |
| PK Parameter: Absolute bioavailability (F) of BIIB122 (DNL151) after oral administration | 21 days |