Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects
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 7% of the time (289 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 2009-04-30, after 2008-12-31 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 2009-04-30. 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: the subjectascendingtolerability pharmacokineticsdiseaseand pharmacodynamics
Phrases that lowered it: healthydays beforescreeningalcoholdrug -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Responsible party: not given (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 135 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 45 (lowers risk) · Who can join
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Sponsor's past trials: 308 (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
- 1 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 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
- 308 (typical: 32)
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 135 (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
- psychiatry
- 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
- A Safety and Tolerability Study of AG-519 in Healthy Subjects NCT02630927 · started 2015 · scored riskier than 1% of active trials terminated
- PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects NCT02387866 · started 2015 · scored riskier than 3% of active trials completed
- Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects NCT01390714 · started 2011 · scored riskier than 0% of active trials completed
- Staccato® Granisetron Single Dose PK NCT04200092 · started 2019 · scored riskier than 4% of active trials completed
- The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH,in Healthy Subjects NCT03655873 · started 2018 · 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.