A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
- Registration Number
- NCT06264440
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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Body mass index between 18 and 30 kilograms per square meter (kg/^m2), inclusive.
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Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.
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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
- Plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the follow-up visit.
- Any condition affecting study treatment absorption.
- History of gastrointestinal surgery, gastroesophageal reflux disease, or other clinically significant and active gastrointestinal condition per the Investigator's discretion.
- Clinically significant acute gastrointestinal symptoms within 30 days prior to study Check-in (Day -1).
- Chronic, recurrent, or serious infection, as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
- 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.
- 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/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Period 3 Rabeprazole Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period. Period 1 BIIB122 Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period. Period 2 Rabeprazole Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period. Period 3 BIIB122 Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period. Period 2 BIIB122 Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Day 55
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States