A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood

Model scores of the 29,894 trials active now.

Model score 5% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-12-06. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Design: crossover (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 108 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: qtsubjectqtcplanned administrationpr
  Phrases that lowered it: healthybioavailabilityvolunteersclinical trialper day
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: none (lowers risk) · Design
• Sponsor's past trials: 540 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 50 (lowers risk) · Who can join
• Number of arms: 3 (lowers risk) · Design

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.

• This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men NCT03349723 · started 2017 · scored riskier than 12% of active trials completed
• This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. NCT03576144 · started 2018 · scored riskier than 12% of active trials completed
• A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men NCT03837964 · started 2019 · scored riskier than 4% of active trials completed
• Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers NCT02273401 · started 2008 · scored riskier than 14% of active trials completed
• Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects NCT03302078 · started 2017 · scored riskier than 4% 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.