Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
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 6% of the time (355 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-04-26, after 2021-02-22 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 2021-04-26. 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: priorrenal endocrineknowncardiaceffective
Phrases that lowered it: healthypharmacokineticsmaleinvestigateinclusive -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 22.2% (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 55 (lowers 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
- 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
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 108 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 8880 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 923 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- 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
- Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers NCT06395610 · started 2024 · scored riskier than 0% of active trials completed
- A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib NCT03398421 · started 2018 · scored riskier than 1% of active trials completed
- Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor NCT03259542 · started 2017 · scored riskier than 1% of active trials completed
- A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 NCT04166669 · started 2019 · scored riskier than 3% 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
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.