Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 3% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2009-10-31, after 2008-10-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2009-10-31. 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: nongenotypedysfunctiondiseasesignificant
Phrases that lowered it: healthyvolunteerspharmacokineticsopensingle dose -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 6.5% (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 35 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 283 (raises risk) · Sponsor's track record
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Sponsor's past trials: 493 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 65 (raises 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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 35 (typical: 18)
- Maximum age
- 65 (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
- 493 (typical: 32)
- Sponsor's past termination rate
- 6.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 283 (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
- neurology, 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
- Pharmacokinetic Interaction Between AZD3480 and Donepezil NCT00713765 · started 2008 · scored riskier than 3% of active trials terminated
- A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144 NCT07518459 · started 2026 · scored riskier than 2% of active trials completed
- AZD2066 Cocktail Study NCT00930306 · started 2009 · scored riskier than 2% of active trials completed
- Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days NCT00686179 · started 2008 · scored riskier than 1% of active trials completed
- Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam NCT05052710 · started 2021 · scored riskier than 2% 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.