Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

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 7% of the time (318 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 2010-05-07. 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
• Sponsor's past termination rate: 22.6% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: tolerabilitythe safetyhepatitis viruspharmacokineticsto assess
  Phrases that lowered it: screeninghealthybody massmass indexinjection
• Phase: 1 (lowers risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 58.4% (lowers risk) · Drug's FDA history
• Design: sequential (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 39 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 6.8% (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Sponsor's past trials: 62 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 8978 (raises risk) · Drug's FDA history
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 1253 (raises risk) · Drug's FDA history

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.

• The Drug -Drug Interaction of SP2086 and Glyburide NCT02815787 · started 2014 · scored riskier than 1% of active trials completed
• Glyburide Healthy Volunteer Study NCT01716338 · started 2013 · scored riskier than 7% of active trials completed
• Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers NCT02183428 · started 2008 · scored riskier than 2% of active trials completed
• Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM NCT01658501 · started 2012 · scored riskier than 10% of active trials completed
• A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects NCT04976270 · started 2021 · scored riskier than 5% 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.