To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-12-31, after 2016-08-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-12-31. 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: heartsyndromeagentsactivedeath
Phrases that lowered it: participanthealthykgsingle dosebody -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: 59.4% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 124 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 7.0% (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 228 (typical: 32)
- Sponsor's past termination rate
- 7.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 124 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 22506 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2860 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- adafosbuvir, drospirenone, ethinyl estradiol, odalasvir, 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
- Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants NCT02824315 · started 2016 · scored riskier than 2% of active trials completed
- Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) NCT03059303 · started 2017 · scored riskier than 2% of active trials terminated
- A Study to Investigate the Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone in Healthy Females NCT03126097 · started 2017 · scored riskier than 2% of active trials terminated
- A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants NCT02945020 · started 2016 · scored riskier than 2% of active trials completed
- E4/DRSP Single and Multiple Dose PK and Early QT Study NCT02874248 · started 2016 · 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.