A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants
Model scores of the 29,894 trials active now.
Model score 4% 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 2014-04-30, after 2014-02-28 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 2014-04-30. 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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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: safety tolerabilityascendingtolerability andand pharmacokineticsplacebo controlled
Phrases that lowered it: participanthealthypharmacokineticparticipantsopen label -
Phase: 1 (lowers risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
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Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 9 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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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: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Keywords listed: 6 (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
- 9 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 20 (typical: 18)
- Maximum age
- 55 (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
- 17 (typical: 32)
- Sponsor's past termination rate
- 5.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 17859 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1951 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ritonavir, simeprevir
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
- TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers NCT00752544 · started 2008 · scored riskier than 4% of active trials completed
- PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir NCT00838760 · started 2009 · scored riskier than 8% of active trials completed
- TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers NCT01288677 · started 2011 · scored riskier than 4% of active trials completed
- TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers. NCT00767117 · started 2008 · scored riskier than 1% of active trials completed
- TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r) NCT01323257 · started 2011 · scored riskier than 1% 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.