A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers

NCT00999128 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2009-10-26 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 8% of the time (544 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 2010-02-26, after 2009-10-26 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 2010-02-26. 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: ventricularto determinepriorcancerdetermine the
Phrases that lowered it: tabletbetween 18healthyvolunteersmale
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Blinding: none (lowers risk) · Design
Drug's FAERS reports with a death: 9.1% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 54 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Number of arms: 2 (raises 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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (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: 63 (typical: 32)
Sponsor's past termination rate: 9.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 54 (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: 5906 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1058 (typical: 412.5)
Drug's FAERS reports marked serious: 71.4% (typical: 85.6%)
Drug's FAERS reports with a death: 9.1% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: rabeprazole

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

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A Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet NCT01240226 · started 2010 · scored riskier than 1% of active trials completed
A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants NCT01249131 · started 2010 · scored riskier than 0% of active trials completed
A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers NCT01980953 · started 2013 · scored riskier than 0% of active trials completed
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants NCT03290703 · started 2017 · scored riskier than 0% 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.