Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal 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 16% of the time (1,938 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-07-12, after 2013-04-24 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2013-07-12. 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: newfollow upof studytreatmentmonths of
Phrases that lowered it: single dosebioavailabilitycrossoverhealthykg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 4.9% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1751 (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 333 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 6 (lowers risk) · Design
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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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 40 (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
- 1751 (typical: 32)
- Sponsor's past termination rate
- 4.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 333 (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
- cancer
- Drugs matched to FDA substances
- afuresertib
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
- Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib NCT02040480 · started 2014 · scored riskier than 0% of active trials completed
- A Study to Look at How GSK1325756 is Taken up by the Body When Given by Mouth When Stomach Acid is Reduced NCT01453478 · started 2011 · scored riskier than 1% of active trials completed
- A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697). NCT01563328 · started 2012 · scored riskier than 3% of active trials completed
- GSK1349572 Relative Bioavailability Study NCT01098513 · started 2010 · scored riskier than 1% of active trials completed
- A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets NCT02925546 · started 2016 · scored riskier than 2% 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.