A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
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 (233 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-13, after 2022-02-10 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 2022-12-13. 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: subjects withocularin subjectsseasonal allergiesallergic disease
Phrases that lowered it: kgbmiand safetysinglethe pharmacokinetics -
Primary purpose: other (lowers risk) · Design
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Sponsor's past termination rate: 0% (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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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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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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Blinding: none (lowers 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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- 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
- 70 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- 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
- A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment NCT05489614 · started 2022 · scored riskier than 4% of active trials completed
- A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment NCT06661733 · started 2024 · scored riskier than 6% of active trials completed
- A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment NCT04752540 · started 2021 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function NCT06698549 · started 2025 · scored riskier than 7% of active trials completed
- Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment NCT04469907 · started 2020 · 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.