Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects

NCT01757756 on ClinicalTrials.gov Phase 1 Pfizer (industry) Started 2012-10-31 Completed

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 (816 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 2012-11-30, after 2012-10-31 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 2012-11-30. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 16.2% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: pfmgassesstolerabilityevidence or
Phrases that lowered it: subjectsinclusivepharmacokineticsbodyexamination
Trials the sponsor started in the prior 2 years: 287 (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Design: single group (raises risk) · Design
Sponsor's past trials: 1163 (raises risk) · Sponsor's track record
Primary purpose: basic science (lowers risk) · Design
Drug's FAERS reports with a death: 23.2% (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: single (lowers risk) · Design
Disease area, psychiatry: 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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: single (typical: 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: 1163 (typical: 32)
Sponsor's past termination rate: 16.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 287 (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: 5086 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 938 (typical: 412.5)
Drug's FAERS reports marked serious: 92.3% (typical: 85.6%)
Drug's FAERS reports with a death: 23.2% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: midazolam

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

Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects NCT01807377 · started 2013 · scored riskier than 8% of active trials completed
A Single Dose Study Of PF-05161704 In Healthy Volunteers NCT01183715 · started 2010 · scored riskier than 4% of active trials completed
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects NCT01923389 · started 2013 · scored riskier than 45% of active trials terminated
A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults NCT01707082 · started 2012 · scored riskier than 18% of active trials completed
A Study Of PF-05175157 In Healthy Volunteers NCT01274663 · started 2010 · scored riskier than 10% 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.