A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-03-31, after 2016-02-29 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 2016-03-31. 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: subject hasthe subjectsubjectsheartsubject is
Phrases that lowered it: healthysinglemalejapanesesafety tolerability -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 13.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (lowers risk) · Design
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Sponsor's past trials: 72 (lowers risk) · Sponsor's track record
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Responsible party: sponsor (lowers risk) · Design
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
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 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
- 72 (typical: 32)
- Sponsor's past termination rate
- 2.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 38 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 23 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- nalmefene
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
- Pharmacokinetic (PK) Evaluation of Nalmefene Formulations NCT07543276 · started 2026 · scored riskier than 0% of active trials completed
- Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens NCT05219669 · started 2021 · scored riskier than 1% of active trials completed
- Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers NCT03129347 · started 2017 · scored riskier than 1% of active trials completed
- A Bioavailability Study With Alternate Methods of Administration of Naloxegol Tablets, and Solution NCT02446171 · started 2015 · scored riskier than 3% of active trials completed
- An Evaluation of The Absolute Bioavailability of TH104 NCT06198686 · started 2024 · 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.