A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants

NCT03023852 on ClinicalTrials.gov Phase 1 Janssen-Cilag International NV (industry) Started 2017-02-14 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% 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 2017-04-14, after 2017-02-14 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 2017-04-14. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: diseasecardiacheartsyndromeagent
Phrases that lowered it: participanthealthysingletabletparticipants
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 2.6% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 11.9% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 8 (lowers risk) · Design
Blinding: none (lowers risk) · Design
Maximum age: 55 (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 68.2% (lowers risk) · Drug's FDA history
Disease area, neurology: 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: 8 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: 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: 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: 38 (typical: 32)
Sponsor's past termination rate: 2.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 8 (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: 10171 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1322 (typical: 412.5)
Drug's FAERS reports marked serious: 68.2% (typical: 85.6%)
Drug's FAERS reports with a death: 11.9% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: oseltamivir, pimodivir

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 Study of JNJ-70033093 (BMS-986177) in Healthy Adult Participants NCT04223349 · started 2020 · scored riskier than 1% of active trials completed
A Study of JNJ-70033093 in Healthy Participants NCT04448964 · started 2020 · scored riskier than 0% of active trials completed
A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation NCT02659735 · started 2015 · scored riskier than 0% of active trials completed
A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants NCT04090086 · started 2019 · scored riskier than 1% of active trials completed
A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants NCT02930694 · 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.