Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac
Model scores of the 29,894 trials active now.
Model score 2% 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 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 2013-12-31, after 2013-07-31 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 2013-12-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectsurgerysafety tolerabilitythe investigatorsdisease
Phrases that lowered it: healthysubject whobloodvolunteersexamination -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Minimum age: 20 (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 11.3% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 19 (lowers risk) · Sponsor's track record
-
Number of arms: 6 (lowers risk) · Design
-
Sponsor's past trials: 14 (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: supportive care (lowers risk) · Design
-
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- supportive care (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 20 (typical: 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
- 14 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 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
- 23641 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3447 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- diclofenac
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
- The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects NCT02176668 · started 2014 · scored riskier than 1% of active trials completed
- YH4808 Postprandial PK/PD Study in Healthy Subjects NCT01761513 · started 2012 · scored riskier than 0% of active trials completed
- Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects NCT01520012 · started 2012 · scored riskier than 0% of active trials completed
- Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects NCT01870674 · started 2013 · scored riskier than 3% of active trials completed
- Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects NCT01657071 · started 2012 · scored riskier than 0% 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.