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The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period. |
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| Period 2 | Experimental | Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period. |
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| Period 3 | Experimental | Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB122 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BIIB122 | Up to Day 55 | |
| Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122 | Up to Day 55 | |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122 | Up to Day 55 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 55 |
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Key Inclusion Criteria:
1. Body mass index between 18 and 30 kilograms per square meter (kg/^m2), inclusive.
3. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.
4. For participants ≥ 55 years of age, ongoing conditions must be considered by the Investigator to be stable and adequately controlled by allowed concomitant medications.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| C000730636 | DNL151 |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | Administered as specified in the treatment arm. |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |