First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology
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 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 2016-05-31, after 2015-05-31 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 2016-05-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subject hasascendingeyemultipletolerability
Phrases that lowered it: healthyeffectasthmamaleinteraction -
Sponsor's past termination rate: 1.8% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 23.2% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 8 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 56 (lowers risk) · Sponsor's track record
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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
- 10 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 56 (typical: 32)
- Sponsor's past termination rate
- 1.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 28 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 13393 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1959 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- itraconazole, midazolam, pilocarpine
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
- A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects NCT04742517 · started 2017 · scored riskier than 4% of active trials completed
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205 NCT02314793 · started 2014 · scored riskier than 2% of active trials terminated
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Non-Japanese Adult and Elderly Subjects and Healthy Japanese Adult Subjects NCT03108755 · started 2017 · scored riskier than 5% of active trials completed
- A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects NCT02136316 · started 2014 · scored riskier than 2% of active trials completed
- A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects NCT02141425 · started 2014 · 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.