First in Man Clinical Trial of Emodepside (BAY 44-4400)
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 6% of the time (340 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-03-27, after 2015-12-31 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 2017-03-27. 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: evidencesafety tolerabilityascendingsubjecteye
Phrases that lowered it: healthyvolunteersthe pharmacokineticspharmacokinetics ofdaily -
Sponsor's past termination rate: 17.6% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 27 (raises 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: 9 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Sponsor's past trials: 17 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 27 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 17 (typical: 32)
- Sponsor's past termination rate
- 17.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- infectious disease, dermatology
- 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
- Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside NCT03383614 · started 2017 · scored riskier than 6% of active trials completed
- Relative Bioavailability Study of Emodepside IR-tablets and Solution NCT03383523 · started 2017 · scored riskier than 5% of active trials completed
- A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants NCT06412926 · started 2024 · scored riskier than 1% of active trials completed
- A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions NCT05665283 · started 2022 · scored riskier than 0% of active trials completed
- A Comparison of the Pharmacokinetic Properties of ARN-75039 Tablets With Excipients to Neat ARN-75039 in Hydroxypropyl Methylcellulose (HPMC) Capsules in Healthy Adult Participants Under Fed Conditions NCT06911242 · started 2025 · scored riskier than 1% 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.