Safety, Tolerability, and Pharmacokinetics Study of Elpipodect (MK-8189) in Participants With Schizophrenia and Healthy Participants (MK-8189-011)
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% 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 2022-03-22, after 2020-08-28 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 2022-03-22. 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: 17.2% (raises risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: safety tolerabilitytolerability andcarcinomamultiplethe safety
Phrases that lowered it: healthymmhgparticipantsscreeningpharmacokinetics of -
Sponsor's past trials: 1293 (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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Trials the sponsor started in the prior 2 years: 130 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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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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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Number of arms: 9 (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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Maximum age: 80 (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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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
- 9 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: 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
- 80 (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
- 1293 (typical: 32)
- Sponsor's past termination rate
- 17.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 130 (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, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007) NCT03565068 · started 2018 · scored riskier than 38% of active trials completed
- A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. NCT04115319 · started 2019 · scored riskier than 55% of active trials completed
- Elpipodect (MK-8189) Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003) NCT02181803 · started 2014 · scored riskier than 16% of active trials completed
- A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3) NCT04738123 · started 2021 · scored riskier than 44% of active trials completed
- A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2) NCT04659161 · started 2020 · scored riskier than 46% 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.