A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
Model scores of the 29,894 trials active now.
Model score 6% 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 2015-05-01, after 2015-02-01 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 2015-05-01. 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
-
Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjecttolerabilityascendingplacebo controlledblind placebo
Phrases that lowered it: healthyscreeningmassbioavailabilityformulations -
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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Blinding: triple (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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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 (raises risk) · Who can join
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Number of arms: 5 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past trials: 22 (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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- triple (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
- 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
- 22 (typical: 32)
- Sponsor's past termination rate
- 18.2% (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
- 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
- daridorexant
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 Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects NCT02571855 · started 2015 · scored riskier than 6% of active trials completed
- A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects NCT03799978 · started 2019 · scored riskier than 0% of active trials completed
- Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-462206 NCT01954589 · started 2011 · scored riskier than 3% of active trials completed
- A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam NCT03017495 · started 2017 · scored riskier than 2% of active trials completed
- A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects NCT03101189 · started 2017 · scored riskier than 4% 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.