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The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts 1 | Experimental | 6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet |
|
| Cohort 2 | Experimental | 6 participants randomized (4:2) to receive a SAD administered orally in tablet(s) |
|
| Cohort 3 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
|
| Cohort 4 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet |
|
| Cohort 5 | Experimental | 8 participants randomized (6:2) to receive a SAD administered orally in tablet(s) |
|
| Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB068 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 9 Days Post dose | |
| Number of participants with clinically significant laboratory assessment abnormalities | Up to 9 Days Post dose | |
| Number of participants with clinically significant Vital sign abnormalities | Up to 9 Days Post dose | |
| Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities | Up to 9 Days Post dose | |
| Number of participants with clinically significant physical examination abnormalities | Up to 9 Days Post dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast) | Up to 48 Hours Post dose | |
| PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf) | Up to 48 Hours Post dose |
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Key Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Research Site | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077329 | Agammaglobulinaemia Tyrosine Kinase |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
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14 participants (all active) to receive a SAD administered orally in tablet(s) |
|
|
| Placebo | Drug | Administered as specified in the treatment arm |
|
| PK Assessment - Maximum observed concentration (Cmax) | Up to 48 Hours Post dose |
| PK Assessment - Time to reach maximum observed concentration (Tmax) | Up to 48 Hours Post dose |
| PK Assessment - Terminal elimination half-life (t1/2) | Up to 48 Hours Post dose |
| PK Assessment - Apparent total body clearance (CL/F) | Up to 48 Hours Post dose |
| PK Assessment - Apparent volume of distribution (Vz/F) | Up to 48 Hours Post dose |
| PK Assessment - Amount of BIIB068 excreted in urine (Aeu) | Up to 48 Hours Post dose |
| PK Assessment - Percentage (%fe) of BIIB068 excreted in urine | Up to 48 Hours Post dose |
| PK Assessment - Renal clearance (CLr) | Up to 48 Hours Post dose |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |