A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure
Model scores of the 29,894 trials active now.
Model score 7% 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 2020-04-08, after 2019-07-31 start.
Reason given by the sponsor: “other”
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 2020-04-08. 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
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 4.5% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
-
Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectssubjectmultipleplanned administrationms
Phrases that lowered it: healthythe effecteffect oftrialblood -
Drug's FAERS reports marked serious: 64.6% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 4 (lowers risk) · Design
-
Sponsor's past trials: 558 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises 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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (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
- 45 (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
- 558 (typical: 32)
- Sponsor's past termination rate
- 6.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 97 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1410 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 102 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- phenelzine, tyramine
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
- This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood NCT03100916 · started 2017 · scored riskier than 3% of active trials completed
- A Study in Healthy Men to Test the Effects of Different Doses of BI 1467335 on MAO-B Activity in the Brain. NCT03927209 · started 2019 · scored riskier than 7% of active trials completed
- A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other NCT03905096 · started 2019 · scored riskier than 3% of active trials completed
- A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men NCT03875001 · 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.