A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers
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 7% of the time (318 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-06-30, after 2022-05-09 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 2022-06-30. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: heart failurediabeticincludingdiseaseprior
Phrases that lowered it: healthyvolunteersproductskgadministration -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Minimum age: 19 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
-
Drug's FAERS reports marked serious: 71.3% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 67 (lowers risk) · Sponsor's track record
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
- 1 (typical: 2)
- Allocation
- not applicable (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
- 19 (typical: 18)
- Maximum age
- 55 (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
- 67 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 458365 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 37398 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- atorvastatin, atorvastatin ezetimibe, ezetimibe, fimasartan
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 Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C. NCT05411965 · started 2022 · scored riskier than 0% of active trials completed
- A Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1018-1 and BR1018-2 in Healthy Adult Subjects NCT05460364 · started 2022 · scored riskier than 0% of active trials completed
- A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers. NCT04485585 · started 2020 · scored riskier than 0% of active trials completed
- A Clinical Trial to Compare the Pharmacokinetics and Safety of BR1016C With BR1016D in Healthy Volunteers NCT05102266 · started 2021 · scored riskier than 0% of active trials completed
- A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers NCT04889651 · started 2021 · 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.