Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 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 5% of the time (4,470 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
Completed on 2010-07-31, after 2010-05-31 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 2010-07-31. 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: childbearing potentialinhibitorsurgical procedureriskhave negative
Phrases that lowered it: crossoveropen labelthe pharmacokineticssequencescreening -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 373 (raises risk) · Sponsor's track record
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Minimum age: 23 (lowers risk) · Who can join
-
Responsible party: not given (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Sponsor's past trials: 811 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 14.5% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 45 (lowers risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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
- 1 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 23 (typical: 18)
- Maximum age
- 45 (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
- 811 (typical: 32)
- Sponsor's past termination rate
- 7.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 373 (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
- 14069 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2611 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- diltiazem, ketoconazole
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
- Determine the Effect of Multiple Doses of AZD7325, CYP Study NCT00790114 · started 2008 · scored riskier than 2% 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
- Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2) NCT00824057 · started 2009 · scored riskier than 3% of active trials completed
- AZD1981 Midazolam CYP4503A Induction Study NCT00859352 · started 2009 · scored riskier than 4% of active trials completed
- This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects NCT01030224 · started 2009 · scored riskier than 8% 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.