A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants

NCT07242781 on ClinicalTrials.gov Phase 1 Celgene (industry) Started 2025-12-15 Terminated

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 in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2026-04-21, after 2025-12-15 start.

Reason given by the sponsor: “business”

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 2026-04-21. 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: bmsheartqtfailureprior
Phrases that lowered it: healthycrossoverparticipantsmaleopen label
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 20.6% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 14.5% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
Maximum age: 60 (lowers risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Blinding: none (lowers risk) · Design
Sponsor's past trials: 330 (lowers risk) · Sponsor's track record
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: non randomized (typical: 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: 8 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 60 (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: 330 (typical: 32)
Sponsor's past termination rate: 20.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 16 (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: 34094 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2702 (typical: 412.5)
Drug's FAERS reports marked serious: 89.2% (typical: 85.6%)
Drug's FAERS reports with a death: 14.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: itraconazole, rifampin

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 Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants NCT05389722 · started 2022 · scored riskier than 1% of active trials completed
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants NCT03950960 · started 2019 · scored riskier than 3% of active trials completed
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects NCT02807909 · started 2016 · scored riskier than 1% of active trials completed
Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165 NCT03930602 · started 2019 · scored riskier than 1% of active trials completed
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects NCT03346837 · started 2017 · scored riskier than 2% 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.