A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects
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
Terminated on 2016-05-31, after 2016-04-30 start.
Reason given by the sponsor: “safety”
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 2016-05-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: priormonthstime ofdays ofallergic disease
Phrases that lowered it: subjects whohealthydrugalcoholmale -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
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Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 34 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 22.7% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports marked serious: 93.0% (raises risk) · Drug's FDA history
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Maximum age: 59 (lowers risk) · Who can join
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: 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
- 18
- Maximum age
- 59 (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
- 113 (typical: 32)
- Sponsor's past termination rate
- 6.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 34 (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
- 8641 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1328 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- midazolam
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
- LEO 32731 - A Study in Healthy Male Subjects NCT01310049 · started 2011 · scored riskier than 3% of active trials completed
- Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam NCT03126578 · started 2017 · scored riskier than 1% of active trials completed
- LEO 22811 - Single Dose Bioavailability Study of Tablet Versus Oral Solution in Healthy Subjects NCT01211964 · started 2010 · scored riskier than 0% of active trials completed
- LEO 27847 - Single Dose Bioavailability Study of Oral Solution Versus Tablet in Healthy Subjects NCT01143298 · started 2010 · scored riskier than 0% of active trials completed
- LEO 27847 - A Study in Healthy Male Subjects NCT01007383 · started 2009 · 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.