To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
Model scores of the 29,894 trials active now.
Model score 5% 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 6% of the time (776 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 2013-03-31, after 2013-02-28 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 2013-03-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: hcvdoubletolerabilityantiviralhepatitis
Phrases that lowered it: healthythe pharmacokineticspharmacokinetics ofopen labelevaluate -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 944 (raises risk) · Sponsor's track record
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Minimum age: 19 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 162 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 10.4% (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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Blinding: none (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- 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
- 19 (typical: 18)
- Maximum age
- 65 (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
- 944 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 162 (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
- 97251 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21862 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- omeprazole, ritonavir, samatasvir
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 Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006) NCT01335607 · started 2011 · scored riskier than 1% of active trials completed
- Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007) NCT01907724 · started 2013 · scored riskier than 6% of active trials completed
- Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004) NCT01813513 · started 2013 · scored riskier than 7% of active trials completed
- A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RO6889678 and the Combination of RO6889678 With Ritonavir in Healthy Participants NCT02321384 · started 2014 · scored riskier than 3% of active trials terminated
- Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects NCT03302182 · started 2017 · 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.