Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

Model scores of the 29,894 trials active now.

Model score 5% 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 2022-05-11. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: safety tolerabilityeffectsmultiplehormonetolerability pharmacokinetics
  Phrases that lowered it: healthyparticipantdrugparticipantsmale
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Sponsor's past trials: 839 (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 99 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 7.5% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: 65.3% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 7.4% (raises risk) · Sponsor's track record
• Blinding: double (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Design: sequential (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 292276 (lowers risk) · Drug's FDA history
• Primary purpose: basic science (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.

• Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested. NCT04027192 · started 2019 · scored riskier than 3% of active trials completed
• First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845 NCT03054402 · started 2017 · scored riskier than 6% of active trials completed
• Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction NCT03048110 · started 2017 · scored riskier than 2% of active trials completed
• BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics NCT03540615 · started 2018 · scored riskier than 5% of active trials completed
• Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects NCT03252002 · started 2017 · scored riskier than 4% 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.