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In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people.
The main question researchers want to answer in this study is:
• How many participants have adverse events (AEs) and serious adverse events (SAEs)?
An AE is a health problem that may or may not be caused by a drug during the study. An AE is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care.
Researchers will also learn more about:
• How the body processes BIIB142
This is a "dose escalation study." This is a study in which increasing amounts of the study drug are given to different groups of participants. This is done until researchers find the highest dose that does not cause harmful effects.
First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. This study will be split into 2 parts - Part A and Part B.
During Part A:
During Part B:
The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A | Experimental | Participants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB142 Cohort 2A | Experimental | Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB142 Cohort 3A | Experimental | Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB142 Cohort 4A | Experimental | Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB142 Cohort 5A | Experimental | Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB142 | Drug | Administered Orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
| Number of Participants with Clinical Laboratory Abnormalities | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
| Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
| Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score | Part B (MAD): Up to Day 29 | |
| Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
| Area Under the Concentration-Time Curve (AUC) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Contact | 866-633-4636 | clinicaltrials@biogen.com | |
| Global Biogen Clinical Trial Center | Contact | clinicaltrials@biogen.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Recruiting | Las Vegas | Nevada | 89113 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Part A (SAD): BIIB142 Cohort 6A | Experimental | Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. |
|
| Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B | Experimental | Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Part B (MAD): BIIB142 Cohort 2B | Experimental | Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Part B (MAD): BIIB142 Cohort 3B | Experimental | Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| BIIB142-Matching Placebo | Drug | Administered Orally |
|
| Maximum Observed Concentration (Cmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
| Time to Maximum Observed Concentration (Tmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
| Apparent Clearance (CL/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
| Apparent Volume of Distribution (Vz/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
| Elimination Half-Life (t1/2) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |