A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)

NCT01798849 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2013-03-15 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 (355 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 2013-07-17, after 2013-03-15 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 2013-07-17. 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
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: safety tolerabilitytolerability pharmacokineticsmultipleand pharmacodynamicshypertension
Phrases that lowered it: healthymoderatekgparticipantsmmhg
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
Sponsor's past trials: 950 (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 161 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Blinding: double (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Maximum age: 60 (lowers risk) · Who can join
Sex: male (lowers risk) · Who can join
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Collaborators: 0 (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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (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: 60 (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: 950 (typical: 32)
Sponsor's past termination rate: 16.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 161 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory
Drugs matched to FDA substances: none matched

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 Single Rising Dose Study of MK-8150 (MK-8150-001) NCT01590810 · started 2012 · scored riskier than 7% of active trials completed
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008) NCT01244035 · started 2010 · scored riskier than 37% of active trials completed
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8150 (MK-8150-002) NCT01656408 · started 2012 · scored riskier than 13% of active trials completed
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1) NCT01446003 · started 2011 · scored riskier than 14% of active trials completed
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002) NCT01096160 · started 2010 · scored riskier than 42% 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.