Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy 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 6% of the time (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-10-13, after 2020-03-18 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 2020-10-13. 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: first dosesubjectof studydose ofhours
Phrases that lowered it: healthysingleevaluate thevisitkg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Collaborators: 2 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
-
Design: sequential (raises risk) · Design
-
Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 65 (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
- 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, digestive
- 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 Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers NCT06334211 · started 2024 · scored riskier than 6% of active trials completed
- Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers NCT03032536 · started 2017 · scored riskier than 5% of active trials terminated
- A Bioavailability Study of FL-101 in Healthy Male and Female Subjects NCT04983732 · started 2021 · scored riskier than 3% of active trials completed
- Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects NCT05278845 · started 2022 · scored riskier than 1% of active trials completed
- Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers NCT05821387 · started 2023 · scored riskier than 6% 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.