Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
Model scores of the 29,894 trials active now.
Model score 2% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-17, after 2018-04-06 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 2018-05-17. 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: diseaseacuteminbilirubindetailed
Phrases that lowered it: healthythe pharmacokineticssingle dosevolunteersand safety -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 5.3% (lowers risk) · Drug's FDA history
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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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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 62.7% (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 45 (lowers risk) · Who can join
-
Disease area, psychiatry: No (lowers risk) · Disease area
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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
- 20 (typical: 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
- 38 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 101341 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11454 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- amlodipine valsartan, rosuvastatin
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
- Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers NCT03009474 · started 2015 · scored riskier than 0% of active trials completed
- Bioequivalence Study of CJ-30061 in Healthy Male Volunteers NCT03657472 · started 2016 · scored riskier than 0% of active trials completed
- To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra NCT01501435 · started 2011 · scored riskier than 0% of active trials completed
- A Study to Compare the Pharmacokinetic Characteristics of CJ-12420 NCT02995239 · started 2015 · scored riskier than 0% of active trials completed
- A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers NCT01925313 · started 2012 · 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.