A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects

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 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 2013-08-31. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: patienthepatitisthe safetyenrollmentsafety tolerability
  Phrases that lowered it: healthysubjectsvolunteersvisitbioavailability
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Design: crossover (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports marked serious: 66.3% (lowers risk) · Drug's FDA history
• Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
• Blinding: triple (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 50 (lowers risk) · Who can join
• Trials the sponsor started in the prior 2 years: 0 (lowers risk) · Sponsor's track record
• Number of arms: 13 (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Disease area, psychiatry: No (lowers risk) · Disease area
• Primary purpose: treatment (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.

• A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects NCT02571140 · started 2013 · scored riskier than 1% of active trials completed
• A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the Treatment of Hypoparathyroidism NCT02152228 · started 2014 · scored riskier than 14% of active trials completed
• Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo NCT05965167 · started 2023 · scored riskier than 1% of active trials completed
• Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism NCT03516773 · started 2018 · scored riskier than 10% of active trials completed
• A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults NCT05137730 · started 2021 · scored riskier than 1% 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.