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Period 2 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 55
Awards & highlights

Study Summary

"This trial aims to see how a medication called rabeprazole affects the way another medication, BIIB122, is processed in the body after a single dose in healthy participants. The study also looks

Who is the study for?
This trial is for healthy individuals with a body mass index (BMI) between 18 and 30, who have tested negative for COVID-19. Participants over 55 should have stable chronic conditions well-managed by permitted medications.Check my eligibility
What is being tested?
The study aims to understand how a common heartburn medication, Rabeprazole, affects the body's handling of BIIB122 after one dose. It also looks at how safe and tolerable BIIB122 is when taken alone or with Rabeprazole.See study design
What are the potential side effects?
While specific side effects are not listed, the trial will monitor participants' reactions to BIIB122 both on its own and in combination with Rabeprazole to assess safety and tolerability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 55
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 55 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122
Maximum Observed Concentration (Cmax) of BIIB122
Secondary outcome measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Period 3Experimental Treatment2 Interventions
Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.
Group II: Period 2Experimental Treatment2 Interventions
Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
Group III: Period 1Experimental Treatment1 Intervention
Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB122
2022
Completed Phase 1
~90
Rabeprazole
2017
Completed Phase 4
~3920

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,304 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,722 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the inclusion criteria for this study allow for participation of individuals aged 55 and above?

"Participants sought for this research must be above 30 years old but under the age of 80."

Answered by AI

Has Period 3 received approval from the FDA?

"The safety rating for Period 3 in this trial is marked as 1, reflecting the early Phase 1 stage with limited available data on both safety and efficacy."

Answered by AI

Which individuals meet the requirements to participate in this research endeavor?

"3. Testing negative for severe acute respiratory syndrome coronavirus (SARS-CoV-2) via polymerase chain reaction at registration."

Answered by AI

Are there openings for new participants in this ongoing clinical trial?

"Yes, the details on clinicaltrials.gov state that this medical study is actively enrolling participants. The trial was initially uploaded on February 12th, 2024, and underwent its latest update on March 13th, 2024. Specifically, recruitment aims to include a total of 15 patients from one designated site."

Answered by AI

What is the upper threshold for the number of individuals enrolled in this medical study?

"Indeed, the details on clinicaltrials.gov demonstrate that this particular research trial is currently in search of eligible participants. The study was initially made public on February 12th, 2024, and its most recent update occurred on March 13th, 2024. Enrollment aims to recruit a total of 15 patients at just one designated site."

Answered by AI

Who else is applying?

What site did they apply to?
PPD Development, LP
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have been in many trials. I feel it helps Doctors figure out how to help people.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
2024. "A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264440.
All > Pflugerville Tx > Paid Studies Austin
~0 spots leftby May 2024
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