The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Model scores of the 29,894 trials active now.
Model score 4% 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 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 2013-07-13, after 2013-03-14 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 2013-07-13. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: placebo controlledascendingcriteria evidence30subject
Phrases that lowered it: alcoholfoodhealthydruggrapefruit -
Primary purpose: other (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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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 4 (lowers risk) · Sponsor's track record
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Keywords listed: 0 (lowers risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- quadruple (typical: 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
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 8 (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
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers NCT03979859 · started 2013 · scored riskier than 5% of active trials completed
- Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers NCT01875939 · started 2013 · scored riskier than 1% of active trials completed
- A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers in Fed Condition NCT05874180 · started 2023 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition NCT01674517 · started 2010 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fasting Condition NCT01674504 · started 2010 · 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.