Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction

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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-07-19. 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: subjects withcarcinomainjuryknownliver
  Phrases that lowered it: the pharmacokineticsthe effecteffect ofhealthyopen label
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Primary purpose: other (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 179 (lowers risk) · Sponsor's track record
• Minimum age: 45 (lowers risk) · Who can join
• Drug's FAERS reports with a death: 21.8% (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 730 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: none (lowers risk) · Design
• Collaborators: 1 (raises 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.

• Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate NCT02671097 · started 2016 · scored riskier than 1% of active trials completed
• Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants NCT03965728 · started 2019 · scored riskier than 4% of active trials completed
• A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate NCT02887443 · started 2016 · scored riskier than 1% of active trials completed
• Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults NCT03264079 · started 2017 · scored riskier than 2% of active trials completed
• 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

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.