To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers

Model scores of the 29,894 trials active now.

Model score 8% 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 2017-08-15. 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
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: qtqtcintervalsubjectsecg
  Phrases that lowered it: healthypharmacokineticssingleinvestigatethe trial
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 102 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past termination rate: 7.1% (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Responsible party: sponsor (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 in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood. NCT03483077 · started 2018 · scored riskier than 14% of active trials terminated
• A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321 NCT03971695 · started 2019 · scored riskier than 12% of active trials completed
• A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood NCT03886272 · started 2019 · scored riskier than 3% of active trials completed
• This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 730357 Are Taken up in the Body and How Well They Are Tolerated NCT03793621 · started 2019 · scored riskier than 8% of active trials completed
• Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects NCT02999191 · started 2017 · scored riskier than 3% 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.