A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150

NCT04334213 on ClinicalTrials.gov Phase 1 Chong Kun Dang Pharmaceutical (industry) Started 2020-05-07 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 1% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2020-08-05, after 2020-05-07 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2020-08-05. 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: tumorstopdiseasecontrastagents
Phrases that lowered it: healthyand safetyadministrationpharmacokineticvolunteers
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 0.8% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Minimum age: 19 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Blinding: none (lowers risk) · Design
Maximum age: 55 (lowers risk) · Who can join
Sponsor's past trials: 128 (lowers risk) · Sponsor's track record
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: 4 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: 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: 19 (typical: 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: 128 (typical: 32)
Sponsor's past termination rate: 0.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 52 (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: 2 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

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

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 Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D759 and D150 (CKD-393) NCT04431687 · started 2020 · scored riskier than 0% of active trials completed
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383. NCT04810676 · started 2021 · scored riskier than 0% of active trials completed
Evaluate the Pharmacokinetics and Safety Between the Treatment of CKD-383 and Treatment of CKD-501, D745, D150, and D029 NCT05897216 · started 2023 · scored riskier than 0% of active trials completed
Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150 NCT05816759 · started 2023 · scored riskier than 0% of active trials completed
Clinical Trial to Evaluate the Drug Drug Interaction of CKD-501 and D308 NCT03616392 · started 2018 · 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.