An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain DAT and SERT Occupancy,Pharmacokinetics and Safety of Single Oral Doses of GSK1360707, Using 11C- PE2I and 11C-DASB as PET Ligands
Model scores of the 29,894 trials active now.
Model score 8% 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 7% of the time (289 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 2009-10-12, after 2009-04-03 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 2009-10-12. 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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Sponsor's past termination rate: 3.9% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: dosesdosepastheartstroke
Phrases that lowered it: safety ofhealthyand safetymmhgmale -
Minimum age: 35 (lowers risk) · Who can join
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Design: single group (raises risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 940 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 40.6% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 478 (raises risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 6 (raises risk) · Design
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Responsible party: sponsor (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
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 35 (typical: 18)
- Maximum age
- 55 (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
- 940 (typical: 32)
- Sponsor's past termination rate
- 3.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 478 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1682 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 274 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 40.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- dopamine, norepinephrine, serotonin
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 Repeat Dose Positron Emission Tomography Study With GSK1144814 NCT01209039 · started 2009 · scored riskier than 9% of active trials completed
- A Positron Emission Tomography (PET) Study to Investigate the Brain Biodistribution of 18F GSK2647544 in Healthy Subjects to Determine Its Ability to Cross the Blood-brain-barrier. NCT01924858 · started 2013 · scored riskier than 4% of active trials terminated
- First Time in Human Study (FTIH) With Positron Emission Tomography (PET) NCT01381419 · started 2008 · scored riskier than 4% of active trials completed
- A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging NCT04038957 · started 2019 · scored riskier than 20% of active trials completed
- A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET NCT06476509 · started 2024 · 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.