Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

Model scores of the 29,894 trials active now.

Model score 6% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-03-31. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: multiplesafety tolerabilitysubjectsdosestolerability and
  Phrases that lowered it: healthyopen labelmaleevaluatean open
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Drug's FAERS reports with a death: 50% (raises risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 159 (lowers risk) · Sponsor's track record
• Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 145 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Disease area, psychiatry: No (lowers risk) · Disease area
• Maximum age: 50 (lowers risk) · Who can join
• Blinding: none (lowers risk) · Design
• Responsible party: sponsor (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.

• Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. NCT01965431 · started 2013 · scored riskier than 2% of active trials completed
• Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers NCT01681277 · started 2012 · scored riskier than 6% of active trials completed
• Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution NCT01835899 · started 2013 · scored riskier than 6% of active trials completed
• Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers NCT01510782 · started 2012 · scored riskier than 6% of active trials completed
• Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects NCT01195688 · started 2010 · 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.