A Phase 1 Study To Characterize The Safety, Tolerability, PK And PK Of Repeat Doses Of PF-06648671 In Healthy Adults And Healthy Elderly Subjects
Model scores of the 29,894 trials active now.
Model score 7% 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 2016-10-31, 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 2016-10-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: tolerabilitysubjects withpfto determineuln
Phrases that lowered it: healthymalekgbodyindex -
Sponsor's past termination rate: 15.8% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1496 (raises risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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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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Drug's FAERS reports with a death: 23.9% (raises risk) · Drug's FDA history
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Maximum age: 85 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 93.3% (raises risk) · Drug's FDA history
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Number of arms: 9 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, psychiatry: No (lowers risk) · Disease area
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Design: not given (raises risk) · Design
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
- 9 (typical: 2)
- Allocation
- randomized
- Design
- not given (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 85 (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
- 1496 (typical: 32)
- Sponsor's past termination rate
- 15.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 214 (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
- 7450 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1071 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- midazolam
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 To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects NCT02539550 · started 2015 · scored riskier than 6% of active trials completed
- Absorption, Metabolism, Excretion and Absolute Bioavailability NCT03250039 · started 2017 · scored riskier than 2% of active trials completed
- A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects NCT04702464 · started 2021 · scored riskier than 4% of active trials completed
- Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin NCT04231435 · started 2019 · scored riskier than 3% of active trials completed
- Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects NCT03983239 · 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.