Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers
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 5% of the time (4,470 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 2014-09-30, after 2012-09-30 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 2014-09-30. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: tolerabilitydosesescalatingsubjectsblind placebo
Phrases that lowered it: healthyvolunteersabnormalvolunteerblood -
Design: crossover (lowers risk) · Design
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Primary purpose: not given (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 75.4% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: No (lowers risk) · Disease area
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Number of arms: 3 (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 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
- 39 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12722 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1798 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- carbidopa, carbidopa levodopa, entacapone, levodopa
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
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers NCT01840423 · started 2013 · scored riskier than 4% of active trials completed
- Safety and Tolerability Study With Single Ascending Doses of ODM-102 NCT01839019 · started 2013 · scored riskier than 4% of active trials completed
- Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers NCT02393950 · started 2015 · scored riskier than 3% of active trials completed
- Impact of Changing the Dosing Regimen on the PK Profile of ODM-203 NCT03240445 · started 2017 · scored riskier than 0% of active trials completed
- Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects NCT02418650 · started 2015 · 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.