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CompletedNCT06264440Updated Jul 19, 2024

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

A Phase 1 interventional study of BIIB122 and Rabeprazole in Healthy Volunteer, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2024, 2 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Body mass index between 18 and 30 kilograms per square meter (kg/\^m2), inclusive.
  1. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.
  1. 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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Period 1

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

    Drug: BIIB122

  • Experimental
    Period 2

    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

  • Experimental
    Period 3

    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

  • DrugBIIB122

    Administered as specified in the treatment arm.

    Also known as: DNL151

  • DrugRabeprazole

    Administered as specified in the treatment arm.

06

What researchers measure

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of BIIB122

    Time frame: Up to Day 55

  2. Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122

    Time frame: Up to Day 55

  3. Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122

    Time frame: Up to Day 55

Secondary outcomes

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

    Time frame: Up to Day 55

07

Study locations

1 site
  • PPD Development, LP
    Austin, Texas 78744, United States
08

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06264440
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Feb 12, 2024
Primary completion
Jun 18, 2024
Completion
Jun 18, 2024
Last update
Jul 19, 2024

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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