TP-3654 Food Effect Study
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 14% of the time (117 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-05-31, after 2024-03-04 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 2024-05-31. 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: time ofdeterminemonths afterincludinglast dose
Phrases that lowered it: healthybioavailabilityparticipantalcoholeffect of -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: other (lowers risk) · Design
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Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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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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Sponsor's past trials: 162 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 4 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Blinding: none (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
- 2
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- other (typical: 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
- 162 (typical: 32)
- Sponsor's past termination rate
- 10.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- none matched
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
- Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654 NCT06389955 · started 2023 · scored riskier than 2% of active trials completed
- Study to Evaluate the Food Effect of TP-05 in Healthy Participants NCT05720364 · started 2023 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants NCT06081699 · started 2019 · scored riskier than 2% of active trials completed
- A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules NCT06178718 · started 2016 · scored riskier than 1% of active trials completed
- Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers NCT05467696 · started 2022 · 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.