A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 7% 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 6% of the time (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-09-27, after 2018-12-21 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 2021-09-27. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 15.0% (raises risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ascendingsafety tolerabilitytolerability andplacebo controlledmultiple
Phrases that lowered it: healthykgbodysmokerssingle -
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 5.9% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 153 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1178 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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
- 11 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (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
- 1178 (typical: 32)
- Sponsor's past termination rate
- 15.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 153 (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
- 3787 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 585 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- iohexol
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
- First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160. NCT00849134 · started 2008 · scored riskier than 8% of active trials completed
- Phase I Study of VLX-1005 in Healthy Subjects NCT04783545 · started 2021 · scored riskier than 6% of active trials completed
- Phase IC Study of Safety and PK of SQ109 300mg Daily NCT01358162 · started 2010 · scored riskier than 6% of active trials completed
- A Study of LY2940094 in Major Depressive Disorder NCT01263236 · started 2010 · scored riskier than 4% of active trials completed
- LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study NCT05957978 · started 2024 · scored riskier than 38% 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.