Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers
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 2015-07-31, after 2015-06-30 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 2015-07-31. 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: csfnegativepriortherapysclerosis
Phrases that lowered it: healthyopenpulmonarythe pharmacokinetics55 -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Primary purpose: not given (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Collaborators: 3 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
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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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Blinding: none (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 75.6% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 17407 (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
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 55 (typical: 18)
- Maximum age
- 75 (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 121667 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17407 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- cromolyn, ibuprofen
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
- Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers NCT04570644 · started 2020 · scored riskier than 8% of active trials completed
- Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease NCT02547818 · started 2015 · scored riskier than 52% of active trials completed
- Pharmacokinetics, Safety & Tolerability of Isotopologs of Atazanavir (ATV), With Pharmacokinetic Comparison to Reyataz NCT01458769 · started 2010 · scored riskier than 2% of active trials completed
- An ADME Study of [14C]AZD4604 and the Absolute Bioavailability of AZD4604 NCT06157255 · started 2024 · scored riskier than 5% of active trials completed
- Multiple Ascending Dose Study of ALZ-801 NCT04157712 · started 2015 · scored riskier than 7% 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.