Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
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 2021-05-18, after 2020-12-18 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 2021-05-18. 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: halflivesdouble blindpriorrandomized double
Phrases that lowered it: bioequivalencehealthybioavailabilityparticipantsperiod -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past trials: 2643 (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 94 (lowers risk) · Sponsor's track record
-
Sponsor's past termination rate: 6.9% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 11.6% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: double (raises risk) · Design
-
Maximum age: 50 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 5 (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (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
- 2643 (typical: 32)
- Sponsor's past termination rate
- 6.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 94 (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
- 69 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- daprodustat
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
- A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™ NCT01597648 · started 2011 · scored riskier than 2% of active trials completed
- Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations NCT04814472 · started 2021 · scored riskier than 0% of active trials completed
- A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804 NCT01313793 · started 2011 · scored riskier than 3% of active trials completed
- Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects NCT05181215 · started 2021 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects NCT06084663 · started 2023 · 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.