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

NCT06264440 | Completed Phase 1 FDA Drug

• 1 other identifier: 283HV104
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Day 55

Study Arms (3)

Period 1

EXPERIMENTAL

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

Drug: BIIB122

Period 2

EXPERIMENTAL

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

Drug: BIIB122; Drug: Rabeprazole

Period 3

EXPERIMENTAL

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

Drug: BIIB122; Drug: Rabeprazole

Interventions

BIIB122 DRUG

Administered as specified in the treatment arm.

Also known as: DNL151

Period 1; Period 2; Period 3

Rabeprazole DRUG

Administered as specified in the treatment arm.

Period 2; Period 3

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Body mass index between 18 and 30 kilograms per square meter (kg/\^m2), inclusive.
• \. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.
• \. For participants ≥ 55 years of age, ongoing conditions must be considered by the Investigator to be stable and adequately controlled by allowed concomitant medications.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

DNL151; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: February 12, 2024
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)