Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-06-30, after 2016-01-31 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 2016-06-30. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: unlesssystemicdays ofallowedsubjects must
Phrases that lowered it: healthygrapefruitlabelinteractionvolunteers -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: 23.0% (raises risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 45 (lowers risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Blinding: none (lowers risk) · Design
-
Responsible party: sponsor (lowers risk) · Design
-
Drug's FAERS reports marked serious: 92.9% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 8288 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1278 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- midazolam, olorofim
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
- Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects NCT03340597 · started 2017 · scored riskier than 2% of active trials completed
- Study of Potential for Interaction of Fluconazole With F901318 NCT02730442 · started 2016 · scored riskier than 2% of active trials completed
- Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males NCT01991327 · started 2014 · scored riskier than 5% of active trials completed
- A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate NCT02887443 · started 2016 · scored riskier than 1% of active trials completed
- Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4 NCT01056575 · started 2010 · 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.