Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
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 16% of the time (1,938 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2011-09-30, after 2011-03-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2011-09-30. 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
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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: in subjectstolerabilitymatchedsubjects withoral doses
Phrases that lowered it: healthythe pharmacokineticskgmoderatesingle -
Primary purpose: not given (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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Has a data monitoring committee: not given (lowers risk) · Design
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, psychiatry: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 1 (raises risk) · Design
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Maximum age: 70 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (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
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, immunology, hematology
- Drugs matched to FDA substances
- alisporivir
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
- Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects NCT02231450 · started 2014 · scored riskier than 4% of active trials completed
- A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar NCT01197911 · started 2010 · scored riskier than 2% of active trials completed
- Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects NCT03189615 · started 2017 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment NCT04634149 · started 2020 · scored riskier than 4% of active trials completed
- Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment. NCT02624557 · started 2015 · 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.