Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote

Model scores of the 29,894 trials active now.

Model score 9% 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 2012-10-31. 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) (raises risk) · Wording Phrases that raised it: ascendingplacebosafety tolerabilitytolerability pharmacokineticsdose study
  Phrases that lowered it: healthysinglevolunteersbmiinclusive
• Primary purpose: other (lowers risk) · Design
• Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Phase: 1 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 5 (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 50 (lowers risk) · Who can join
• Sponsor's past trials: 8 (lowers risk) · Sponsor's track record
• Disease area, psychiatry: No (lowers risk) · Disease area

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.

• Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4) NCT03551730 · started 2012 · scored riskier than 8% of active trials completed
• Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4) NCT01758432 · started 2012 · scored riskier than 8% of active trials completed
• Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4) NCT03578146 · started 2012 · scored riskier than 8% of active trials completed
• Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4) NCT03551743 · started 2012 · scored riskier than 8% of active trials completed
• Dose Escalation Study of PF-06741086 In Healthy Subjects NCT02531815 · started 2015 · scored riskier than 17% 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.