Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
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 5% of the time (176 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-07-15, after 2018-06-13 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 2018-07-15. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: effectivetrial ofsubjects mustto assessphase
Phrases that lowered it: healthyeffectpharmacokineticsopen labelsingle dose -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Sponsor's past termination rate: 4% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Minimum age: 19 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
-
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
-
Maximum age: 55 (lowers risk) · Who can join
-
Blinding: none (lowers risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Disease area, psychiatry: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 9 (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
- 25 (typical: 32)
- Sponsor's past termination rate
- 4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 6471 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 626 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- itraconazole
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
- SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects NCT02657122 · started 2015 · scored riskier than 8% of active trials completed
- TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects NCT03408470 · started 2018 · scored riskier than 2% of active trials completed
- A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211 NCT01568411 · started 2012 · scored riskier than 2% of active trials completed
- TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects NCT01655771 · started 2012 · scored riskier than 6% of active trials completed
- Single Ascending Dose Study of TD-1439 in Healthy Subjects NCT02903095 · started 2016 · scored riskier than 10% 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.