Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment

Phase 1

Active, not recruiting

• Conditions: Insomnia; Renal Impairment
• Interventions: Drug: YZJ-1139

• Registration Number: NCT06671444
• Lead Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Brief Summary

Objective：

1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.

2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04
• Primary Completion: 2024-11-10
• Study Completion: 2024-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A: Severe Renal Impairment	YZJ-1139	-
Group B: Normal Renal Impairment	YZJ-1139	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) 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
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139	From Day 1 to Day 3	AUCinf is defined as the concentration of drug extrapolated to infinite time
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139	From Day 1 to Day 3	Cmax is defined as the maximum concentration of drug
renal clearance (CLR) of YZJ-1139	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
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
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 to Day 7
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
Renal Excretion (Ae) of YZJ-1139	From Day 1 to Day 3
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib	From Day 1 to Day 3
Mean Residence Time (MRT0-t) of YZJ-1139	From Day 1 to Day 3

Trial Locations

Locations (3)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, China

The First Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, China