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

NCT06264440 on ClinicalTrials.gov Phase 1 Biogen (industry) Started 2024-02-12 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-06-18, after 2024-02-12 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-06-18. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: allowedpriorrecurrentacutetherapy
Phrases that lowered it: healthyparticipantssingle doseevaluate the55 years
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 21.0% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Minimum age: 30 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 12.6% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 80 (raises risk) · Who can join
Blinding: none (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports before start: 41213 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 30 (typical: 18)
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 329 (typical: 32)
Sponsor's past termination rate: 21.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 18 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 41213 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1948 (typical: 412.5)
Drug's FAERS reports marked serious: 85.8% (typical: 85.6%)
Drug's FAERS reports with a death: 12.6% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: rabeprazole

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood NCT05467475 · started 2022 · scored riskier than 4% of active trials completed
Study of BIIB091 Formulations in Healthy Participants NCT04564612 · started 2020 · scored riskier than 2% of active trials completed
A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood NCT06419660 · started 2024 · scored riskier than 4% of active trials completed
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants NCT05148481 · started 2021 · scored riskier than 8% of active trials completed
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD) NCT02637557 · started 2016 · scored riskier than 27% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.