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

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Open-Label, Crossover Study to Assess the Potential for Gastric pH-Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06264440
• Other study ID #: 283HV104
• Status: Completed
• Phase: Phase 1
• Start date: February 12, 2024
• Est. completion date: June 9, 2024

Study information

• Verified date: June 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 9, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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/Exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• BIIB122
Administered as specified in the treatment arm.
• Rabeprazole
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of BIIB122		Up to Day 55
Primary	Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122		Up to Day 55
Primary	Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122		Up to Day 55
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Day 55