A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han 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 11% of the time (918 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.
How it ended
Completed on 2009-12-31, after 2009-07-31 start.
The score above never used this outcome: 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.
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 2009-12-31. 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: riskand datedincludinginvestigational drugcomply with
Phrases that lowered it: healthythe pharmacokineticssinglesubjectsevaluate the -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: not given (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 55.4% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 5.0% (lowers risk) · Drug's FDA history
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Keywords listed: 10 (raises risk) · Design
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Blinding: none (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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
- 3 (typical: 2)
- Allocation
- not given (typical: randomized)
- Design
- parallel
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 15306 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3477 (typical: 412.5)
- Drug's FAERS reports marked serious
- 55.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- duloxetine
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
- Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females NCT00818155 · started 2009 · scored riskier than 8% of active trials completed
- Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition NCT02291341 · started 2008 · scored riskier than 0% of active trials completed
- Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition NCT02291367 · started 2008 · scored riskier than 0% of active trials completed
- Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions NCT04723238 · started 2021 · scored riskier than 0% of active trials completed
- Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions NCT04751318 · started 2021 · 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.