A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth 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 8% of the time (544 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 2016-08-04. 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: tolerabilitysubjectascendingplacebo controlledevidence
  Phrases that lowered it: administrationdrugshcvdosethe pharmacokinetics
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 8.6% (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Sponsor's past trials: 860 (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 26.7% (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 154 (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Blinding: double (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 94.2% (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
• Drug's FAERS reports before start: 4931 (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.

• A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants NCT03040635 · started 2017 · scored riskier than 4% of active trials completed
• A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants NCT03988907 · started 2019 · scored riskier than 3% of active trials completed
• A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants NCT02908685 · started 2016 · scored riskier than 47% of active trials completed
• A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers NCT01708616 · started 2012 · scored riskier than 2% of active trials completed
• A Study of RO5285119 in Healthy Volunteers NCT01418963 · started 2011 · scored riskier than 6% 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.