A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants

NCT06568458 on ClinicalTrials.gov Phase 1 Bristol-Myers Squibb (industry) Started 2024-09-19 Completed

Riskier than 1% of active trials

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 2025-02-27, after 2024-09-19 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 2025-02-27. 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: bmsplaceboevidencephaseorgan
Phrases that lowered it: participanttablethealthyparticipantsbioavailability
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 10.9% (raises risk) · Sponsor's track record
Sponsor's past trials: 951 (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 69.4% (lowers risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Design: sequential (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: 8 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 951 (typical: 32)
Sponsor's past termination rate: 10.9% (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: 26265 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4494 (typical: 412.5)
Drug's FAERS reports marked serious: 69.4% (typical: 85.6%)
Drug's FAERS reports with a death: 21.1% (typical: 15.9%)

Disease area and drugs

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

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 Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants NCT04536961 · started 2020 · scored riskier than 0% of active trials completed
A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants NCT05350800 · started 2022 · scored riskier than 2% of active trials completed
Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants NCT06417229 · started 2024 · scored riskier than 2% of active trials completed
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants NCT05852769 · started 2023 · scored riskier than 1% of active trials completed
A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants NCT04305899 · started 2020 · 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.