A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

NCT04099732 on ClinicalTrials.gov Phase 1 Boehringer Ingelheim (industry) Started 2019-10-07 Completed

Riskier than 3% of active trials

Model scores of the 29,894 trials active now.

Model score 4% 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 2019-12-10, after 2019-10-07 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 2019-12-10. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: pressuremmhgbrainheartgreater than
Phrases that lowered it: healthymaleadministrationtrialbioavailability
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 6.0% (lowers risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 95 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 5.5% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 64.9% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 120754 (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Blinding: none (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 568 (raises risk) · Sponsor's track record

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: 2
Allocation: non randomized (typical: randomized)
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (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: 568 (typical: 32)
Sponsor's past termination rate: 6.0% (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: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 120754 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13742 (typical: 412.5)
Drug's FAERS reports marked serious: 64.9% (typical: 85.6%)
Drug's FAERS reports with a death: 5.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: 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 the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood NCT04257032 · started 2020 · scored riskier than 4% of active trials completed
A Study in Healthy Men and Women to Test How Well Different Doses of BI 1323495 Are Tolerated NCT04107805 · started 2019 · scored riskier than 6% of active trials completed
This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam NCT03325712 · started 2017 · scored riskier than 11% 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
A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body NCT04267276 · started 2020 · scored riskier than 7% 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.