Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (81 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-08-03, after 2020-11-25 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 2021-08-03. 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: hepatitisinabilitychronicexpectedvirus
Phrases that lowered it: healthyfirst dosemmhgvolunteerssubject who -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 19 (lowers risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 160 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 611 (raises risk) · Sponsor's track record
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Number of arms: 4 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports marked serious: 71.2% (lowers risk) · Drug's FDA history
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Maximum age: 50 (lowers 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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- 50 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 611 (typical: 32)
- Sponsor's past termination rate
- 5.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 160 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 210002 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16184 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- atovaquone, atovaquone proguanil, esomeprazole, proguanil, tegoprazan, vonoprazan
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
- Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants NCT03814642 · started 2019 · scored riskier than 0% of active trials completed
- Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers NCT04231136 · started 2020 · scored riskier than 0% of active trials completed
- PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers NCT05162053 · started 2021 · scored riskier than 0% of active trials completed
- Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study NCT02572375 · started 2014 · scored riskier than 1% of active trials completed
- Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin NCT02157649 · started 2014 · 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.