Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

NCT02236988 on ClinicalTrials.gov Phase 1 Amgen (industry) Started 2014-01-07 Completed

Among the lowest-risk 1% of active trials

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 2014-09-11, after 2014-01-07 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 2014-09-11. 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: dsmobtainednondefinedunless
Phrases that lowered it: healthyhepatitishcvvirusmale subjects
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Primary purpose: other (lowers risk) · Design
Drug's FAERS reports marked serious: 57.1% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 8.9% (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 55 (lowers risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor's past trials: 315 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 4 (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: 4 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: other (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 55 (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: 315 (typical: 32)
Sponsor's past termination rate: 8.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 90 (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: 7 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4 (typical: 412.5)
Drug's FAERS reports marked serious: 57.1% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (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 the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects NCT02802735 · started 2016 · scored riskier than 1% 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
Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults NCT01634191 · started 2012 · scored riskier than 2% 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
A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults NCT02777554 · started 2016 · 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.