Pharmacokinetic Study of GB-5001A 280 mg Long Acting Injection, in Comparison With the Comparator Drug Aricept® 5 mg and Aricept® 10 mg Film-coated Tablet in Healthy Subjects
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 (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2026-04-15, after 2025-08-12 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 2026-04-15. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: donepezilsubjects withfunctionulnhormonal
Phrases that lowered it: healthytabletbioavailabilityblood pressuremmhg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Minimum age: 19 (lowers risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports with a death: 15.7% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Blinding: none (lowers risk) · Design
-
Drug's FAERS reports marked serious: 76.0% (lowers 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 38203 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2630 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- donepezil
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
- Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers NCT05525780 · started 2022 · scored riskier than 4% of active trials completed
- Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers NCT02501109 · started 2015 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets (Man. by: P&C Labs (Pellets & CR Products), Egypt) Versus Abilify 10 mg Orodispersible Tablets (Otsuka Pharmaceutical Netherlands B.V., Netherlands) NCT05804721 · started 2022 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects NCT06043297 · started 2023 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet NCT06817811 · started 2021 · 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.