Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production
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 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 2016-10-31, after 2016-04-30 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 2016-10-31. 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: priorsubjecthighctdisease
Phrases that lowered it: healthyvolunteerspharmacokineticmalebody -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers 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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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Blinding: none (lowers 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: 0 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 9 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tricaprylin
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
- Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production NCT02833012 · started 2016 · scored riskier than 0% of active trials completed
- Evaluation of PK of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production NCT02959710 · started 2016 · scored riskier than 0% of active trials completed
- Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production NCT03063645 · started 2017 · scored riskier than 0% of active trials completed
- A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects NCT01611467 · started 2012 · scored riskier than 1% of active trials completed
- Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production NCT03971123 · started 2019 · 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.