TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.

NCT00828815 on ClinicalTrials.gov Phase 1 Tibotec Pharmaceuticals, Ireland (industry) Started 2009-03-31 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 1% 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 2009-11-30, after 2009-03-31 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 2009-11-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: multiplestabletherapyevidenceprotein
Phrases that lowered it: drugkgbodyto investigateopen label
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 4% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Responsible party: not given (raises risk) · Design
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 5.0% (lowers risk) · Drug's FDA history
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 21 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 95.5% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Number of arms: not given (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 25 (lowers risk) · Sponsor's track record
Maximum age: 55 (lowers risk) · Who can join
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: not given (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 0
Keywords listed: 8 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 55 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 25 (typical: 32)
Sponsor's past termination rate: 4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 21 (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: 242 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 159 (typical: 412.5)
Drug's FAERS reports marked serious: 95.5% (typical: 85.6%)
Drug's FAERS reports with a death: 5.0% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, immunology, urogenital
Drugs matched to FDA substances: etravirine

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

TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State. NCT00744770 · started 2008 · scored riskier than 3% of active trials completed
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults NCT01908842 · started 2013 · scored riskier than 53% of active trials completed
A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone NCT00915564 · started 2009 · scored riskier than 6% of active trials completed
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone NCT02666001 · started 2016 · scored riskier than 4% of active trials completed
Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045) NCT02715700 · started 2015 · scored riskier than 5% 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.