Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325

NCT00681720 on ClinicalTrials.gov Phase 1 AstraZeneca (industry) Started 2008-02-29 Completed

Riskier than 4% of active trials

Model scores of the 29,894 trials active now.

Model score 4% 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 7% of the time (289 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 2008-07-31, after 2008-02-29 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 2008-07-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: to determinemripetimagingcentral
Phrases that lowered it: healthyvolunteerskgopen labelin clinical
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Disease area, psychiatry: Yes (raises risk) · Disease area
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 54.8% (raises risk) · Drug's FDA history
Responsible party: not given (raises risk) · Design
Minimum age: 20 (lowers risk) · Who can join
Design: single group (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 225 (raises risk) · Sponsor's track record
Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 96.8% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 45 (lowers risk) · Who can join
Blinding: none (lowers risk) · Design
Sponsor's past trials: 374 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: basic science (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: 1 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 0
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 45 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 374 (typical: 32)
Sponsor's past termination rate: 7.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 225 (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: 31 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14 (typical: 412.5)
Drug's FAERS reports marked serious: 96.8% (typical: 85.6%)
Drug's FAERS reports with a death: 54.8% (typical: 15.9%)

Disease area and drugs

Disease areas: psychiatry
Drugs matched to FDA substances: flumazenil, phenyl

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

Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 NCT00681746 · started 2008 · scored riskier than 4% of active trials completed
Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects NCT00686413 · started 2008 · scored riskier than 5% of active trials completed
A Study to Examine the Distribution of PF-06372865 in the Brain of Healthy Volunteers Using Positron Emission Tomography and a Radioactive Tracer Following Oral Administration of One Dose of PF-06372865 NCT02138500 · started 2014 · scored riskier than 3% of active trials completed
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516 NCT00892944 · started 2009 · scored riskier than 2% of active trials completed
Basmisanil Positron Emission Tomography Study in Japanese Volunteers NCT02534207 · started 2015 · 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.