Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets 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 9% of the time (238 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-07-11, after 2022-06-25 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 2022-07-11. 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: egfrvaccinecreatinineserumventricular
Phrases that lowered it: healthyvolunteersalcoholdrugdrugs -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 142 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 21.5% (raises risk) · Drug's FDA history
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Sponsor's past trials: 183 (lowers risk) · Sponsor's track record
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: 45 (lowers risk) · Who can join
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 183 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 142 (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
- 9912 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 728 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- itraconazole
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 I Study of SHR1459 in Healthy Subjects NCT04455100 · started 2020 · scored riskier than 1% of active trials completed
- IMP4297 DDI (Drug-Drug Interaction)Trial in Healthy Male Volunteers NCT04584515 · started 2020 · scored riskier than 1% of active trials completed
- Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects NCT05828485 · started 2022 · scored riskier than 0% of active trials completed
- Study on the Bioavailability of SHR0302 in Healthy Subjects NCT04712838 · started 2021 · scored riskier than 0% of active trials completed
- A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers NCT04395053 · started 2020 · 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.