A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: BIIB122; Drug: Rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06264440

283HV104

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Body mass index between 18 and 30 kilograms per square meter (kg/^m2), inclusive.

2. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.

3. 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/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

Period 1

Experimental group

Description:

Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period.

Treatment:

Drug: BIIB122

Period 2

Experimental group

Description:

Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.

Treatment:

Drug: Rabeprazole

Drug: BIIB122

Period 3

Experimental group

Description:

Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.

Treatment:

Drug: Rabeprazole

Drug: BIIB122