Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
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 11% of the time (918 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 2009-07-31, after 2009-03-31 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 2009-07-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: safety tolerabilitypharmacokinetics andeffectsacutecardiac
Phrases that lowered it: volunteershealthydiseasesintendedthe pharmacokinetics -
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
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Drug's FAERS reports with a death: 4.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 62.3% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
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Primary purpose: basic science (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
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 13 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 16017 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3439 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- efavirenz, ezetimibe
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 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion NCT02085967 · started 2014 · scored riskier than 4% of active trials completed
- CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers NCT02288338 · started 2014 · scored riskier than 0% of active trials completed
- Acotral® Versus Zetia® Ezetimibe Bioequivalance Study. NCT01597700 · started 2012 · scored riskier than 0% of active trials completed
- A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects NCT06547359 · started 2024 · scored riskier than 2% of active trials completed
- Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects NCT04543370 · started 2020 · scored riskier than 1% 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.