A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood
Model scores of the 29,894 trials active now.
Model score 9% 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 2024-06-14, after 2023-05-01 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 2024-06-14. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: safety tolerabilitytolerability pharmacokineticsmultiplesubjectsof bi
Phrases that lowered it: healthyopen labelkgeffect ofthe pharmacokinetics -
Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 95 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 732 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 74.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 270585 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 20625 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 7 (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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 7 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: 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
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 732 (typical: 32)
- Sponsor's past termination rate
- 8.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 95 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 270585 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20625 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- digoxin, midazolam, rosuvastatin
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 BI 1839100 is Taken up and Handled by the Body NCT06572111 · started 2024 · scored riskier than 6% of active trials terminated
- A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food NCT04801693 · started 2021 · scored riskier than 21% of active trials completed
- A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0003) NCT05934955 · started 2023 · scored riskier than 16% of active trials completed
- A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food NCT05337592 · started 2022 · scored riskier than 8% of active trials completed
- A Study to Test How BI 1819479 is Taken up and Processed by the Body NCT07065617 · started 2025 · scored riskier than 6% of active trials terminated
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.