Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults
Model scores of the 29,894 trials active now.
Model score 2% 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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-01-12, after 2024-12-01 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 2025-01-12. 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: to determinesubjectspriorhepatitiseffective
Phrases that lowered it: mmhgkghealthysingletablets -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 16.7% (lowers risk) · Drug's FDA history
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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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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 97.5% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: 45 (lowers risk) · Who can join
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Primary purpose: treatment (raises 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 594 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 175 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, metabolic, endocrine
- Drugs matched to FDA substances
- mirogabalin
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
- Drug Interaction and Food Effect Study of CS0159 NCT07429331 · started 2026 · scored riskier than 0% of active trials completed
- Safety Study of Two Oral Formulations of MGCD265 Administered in Healthy Subjects in the Fasting State NCT01930006 · started 2013 · scored riskier than 7% of active trials completed
- A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants NCT05067439 · started 2021 · scored riskier than 4% of active trials completed
- A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion NCT02085967 · started 2014 · scored riskier than 4% of active trials completed
- Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir NCT05513625 · started 2020 · scored riskier than 3% 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.