A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

NCT01115985 on ClinicalTrials.gov Phase 1 Astellas Pharma Inc (industry) Started 2010-03-31 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 2010-04-30, after 2010-03-31 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 2010-04-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: heartmethodto assessliverassess the
Phrases that lowered it: healthyinteractionpharmacokineticcrossoverbody
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Primary purpose: not given (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Minimum age: 20 (lowers risk) · Who can join
Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
Responsible party: not given (raises risk) · Design
Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 108 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 76.2% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 214 (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 8281 (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Maximum age: 44 (lowers risk) · Who can join
Drug's FAERS reports before start: 46490 (lowers risk) · Drug's FDA history
Disease area, psychiatry: 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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: not given (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 44 (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: 214 (typical: 32)
Sponsor's past termination rate: 6.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 108 (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: 46490 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8281 (typical: 412.5)
Drug's FAERS reports marked serious: 76.2% (typical: 85.6%)
Drug's FAERS reports with a death: 7.2% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: atorvastatin

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 Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers NCT01115946 · started 2010 · scored riskier than 0% of active trials completed
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers NCT01115972 · started 2010 · scored riskier than 0% of active trials completed
Drug Interaction Study of ASC42 With Atorvastatin NCT05464628 · started 2022 · scored riskier than 1% of active trials completed
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin NCT01635946 · started 2012 · scored riskier than 2% of active trials completed
Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects NCT01765023 · started 2012 · 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.