A Study to Evaluate the Safety of K-755 in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 5% 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 2019-11-14, after 2018-02-27 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 2019-11-14. 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: subject hasascendingtolerabilityadministrationtype
Phrases that lowered it: healthyvolunteerseffectinvestigatefood -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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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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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.6% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: 17.2% (lowers risk) · Drug's FDA history
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Number of arms: 8 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Design: sequential (raises risk) · Design
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Drug's FAERS reports before start: 29 (lowers risk) · Drug's FDA history
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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
- 8 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- double (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
- 45 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 29 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- adenine
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 Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers NCT01952548 · started 2013 · scored riskier than 4% of active trials completed
- A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation NCT03434977 · started 2018 · scored riskier than 1% of active trials completed
- A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199 NCT03880487 · started 2019 · scored riskier than 4% of active trials terminated
- [KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001 NCT05017870 · started 2018 · scored riskier than 4% of active trials completed
- Single Ascending Dose (SAD)/Multiple Ascending Dose(MAD) Safety/Pharmacokinetic (PK) Study of KM-023 NCT01348516 · started 2011 · scored riskier than 2% 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.