Recent Updates
Recently added Catalysts

YZJ-1139

Phase 1

Insomnia | Small molecule | Gastrointestinal |Co-Diagnostics, Inc.|Last Updated: Nov 4, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06671509Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic ImpairmentPHASE1 COMPLETED 24Mar 22, 2024Aug 7, 2024Nov 4, 20241 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
From Day 1 to Day 3

Cmax is defined as the maximum concentration of drug

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of YZJ-1139
From Day 1 to Day 3

AUCinf is defined as the concentration of drug extrapolated to infinite time

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of YZJ-1139
From Day 1 to Day 3

AUClast is defined as the concentration of drug from time zero to the last observable concentration

Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib
From Day 1 to Day 3

Tmax is defined as the time (observed time point) of Cmax.

Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
From Day 1 to Day 3
Apparent Oral Clearance (CL/F) of Entrectinib
From Day 1 to Day 3

CL/F is defined as the apparent oral clearance following administration of the drug

The Apparent Volume of Distribution (Vz/F) of Entrectinib
From Day 1 to Day 3

Vz/F is defined as the apparent volume of distribution of the drug

Secondary Endpoints
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 to Day 7
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A: Mild Hepatic ImpairmentEXPERIMENTAL -
Group B: Moderate Hepatic ImpairmentEXPERIMENTAL -
Group C: Normal Hepatic ImpairmentEXPERIMENTAL -
Interventions
NameTypeDescription
YZJ-1139DRUGSingle oral dose, 20 mg tablet
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Voluntarily sign an informed consent form before the start of activities related to this trial, and be able to understand the procedures and methods of this trial, willing to strictly follow the clinical trial protocol to complete this trial; 2. The subjects (including partne...

Countries:China
Unlock Eligibility Criteria