Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
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 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 2016-08-05, after 2016-06-22 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 2016-08-05. 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: multiplesubjectadministration orsubjects mustdisease
Phrases that lowered it: healthythe pharmacokineticsadultopen labelsingle -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 19.9% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 76 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 0.7% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 5 (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (lowers risk) · Design
-
Disease area, psychiatry: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 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
- 412 (typical: 32)
- Sponsor's past termination rate
- 10.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 76 (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
- 19162 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13460 (typical: 412.5)
- Drug's FAERS reports marked serious
- 19.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- apremilast
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
- Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men NCT02236988 · started 2014 · scored riskier than 0% of active trials completed
- Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults NCT01634191 · started 2012 · scored riskier than 2% of active trials completed
- Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults NCT01634178 · started 2012 · scored riskier than 0% of active trials completed
- Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension NCT02641353 · started 2016 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects NCT06084663 · started 2023 · 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.