Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
Model scores of the 29,894 trials active now.
Model score 6% 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 2011-07-31, after 2011-03-31 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 2011-07-31. 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: subjectstolerabilityascendingmultipledoses
Phrases that lowered it: smokershealthycrossovermaleproduct -
Trials the sponsor started in the prior 2 years: 330 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 50% (lowers risk) · Drug's FDA history
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Minimum age: 20 (lowers risk) · Who can join
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 939 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: basic science (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 80 (raises risk) · Who can join
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Sponsor's past termination rate: 7.8% (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Disease area, psychiatry: 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
- 2
- Allocation
- randomized
- Design
- 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
- 4 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 80 (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
- 939 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 330 (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
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1 (typical: 412.5)
- Drug's FAERS reports marked serious
- 50% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- naloxegol
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
- Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects NCT01365000 · started 2011 · scored riskier than 2% of active trials completed
- Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 NCT01520896 · started 2012 · scored riskier than 2% of active trials completed
- Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese NCT01679028 · started 2012 · scored riskier than 2% of active trials completed
- A Study of NKTR-358 (LY3471851) in Healthy Participants NCT04380324 · started 2017 · scored riskier than 3% of active trials completed
- Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants NCT02706834 · started 2016 · scored riskier than 5% 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.