Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGBIIB122
Administered as specified in the treatment arm.
DRUGRabeprazole
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
1. Plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the follow-up visit. 2. Any condition affecting study treatment absorption. 3. History of gastrointestinal surgery, gastroesophageal reflux disease, or other clinically significant and active gastrointestinal condition per the Investigator's discretion. 4. Clinically significant acute gastrointestinal symptoms within 30 days prior to study Check-in (Day -1). 5. Chronic, recurrent, or serious infection, as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1. 6. For participants \< 55 years of age: Use of any prescription medication (excluding oral contraceptives and hormone replacement therapy), OTC oral medications including proton pump inhibitors (PPI), histamine H2-receptor antagonists (H2 blockers), and antacids (excluding acetaminophen and aspirin ≤ 100 mg daily), or nutraceuticals including vitamins/mineral supplements/herbal medicines within 28 days prior to Day -1 and throughout the study. 7. For participants ≥ 55 years of age: Up to 5 medications are allowed if they are taken at a stable dose level and regimen. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 55 |
Countries
United States
Outcome results
None listed