Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-10-28, after 2025-08-20 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-10-28. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: priorhighto determinecancerbreast
Phrases that lowered it: healthyparticipantsvaccineopen labelcrossover -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 38.5% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 1.3% (lowers risk) · Drug's FDA history
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Maximum age: 50 (lowers risk) · Who can join
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Disease area, neurology: 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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 13 (typical: 32)
- Sponsor's past termination rate
- 38.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6045 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 393 (typical: 412.5)
- Drug's FAERS reports marked serious
- 17.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- sapropterin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Phase 1 Study of SMP-100 in Normal Healthy Volunteers NCT04296799 · started 2020 · scored riskier than 4% of active trials completed
- Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets NCT03100838 · started 2017 · scored riskier than 0% of active trials completed
- A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate NCT05349435 · started 2022 · scored riskier than 3% of active trials terminated
- A Phase 1 Clinical Trial DHP2306R1 and DHP2306R2 in Healthy Adult Volunteers NCT06395155 · started 2023 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block NCT02466347 · started 2014 · scored riskier than 0% 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.