A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects
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 2022-10-20, after 2022-10-01 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 2022-10-20. 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: hepatitistreatmentillnesspriorsubject
Phrases that lowered it: healthyscreeninginvestigatormalethe effect -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (lowers risk) · Design
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Maximum age: 55 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 11 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 21.3% (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 84 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 10128 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 658 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- itraconazole
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
- To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100 NCT05684718 · started 2023 · scored riskier than 1% of active trials completed
- A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants NCT04090047 · started 2019 · scored riskier than 4% of active trials completed
- An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults. NCT02883114 · started 2016 · scored riskier than 4% of active trials completed
- Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants NCT05203822 · started 2022 · scored riskier than 2% of active trials completed
- A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants NCT03928327 · started 2019 · 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.