NCT05919017

Exploring the PK of Different Doses of Naltrexone in Patients With AUD

Exploring the Pharmacokinetic Characteristics of Different Doses of Naltrexone Implants in Patients With Alcohol Use Disorders

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Design This study is related to a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of different doses of naltrexone implants in the treatment of patients with alcohol use disorders (protocol No.: SK2007-NQT-201, hereinafter referred to as II). This study plans to include 60 patients who are interested in participating in this study in Phase II patients, collect PK blood samples from patients, and conduct PK characteristic analysis. The collected plasma samples will be temporarily stored in a -80 ℃ refrigerator and tested after unblinding in Phase II.

Detailed description

Research Design This study is related to "a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of different doses of naltrexone implants in the treatment of patients with alcohol use disorders" (protocol No.: SK2007-NQT-201, hereinafter referred to as II). This study plans to include 60 patients who are interested in participating in this study in Phase II patients, collect PK blood samples from patients, and conduct PK characteristic analysis. The collected plasma samples will be temporarily stored in a -80 ℃ refrigerator and tested after unblinding in Phase II. Research process and PK blood collection Twelve blood samples were collected from each patient, about 4mL of venous blood were collected 0 h before administration (within 4h before administration) and 4h, 12h, D1 (24h), D7, D14, D28, D56, D84, D112, D140, D168 days after administration. At the planned blood collection point, collect approximately 4mL of blood sample into a labeled heparin sodium anticoagulant vacuum collection vessel. After collecting each tube of blood, gently invert it back and forth immediately and pay attention to hemolysis to fully mix the blood with anticoagulants to ensure anticoagulant effect. After sample collection and before centrifugation, the blood sample needs to be placed upright in an ice water bath and transported to the sample pretreatment room. Within 1 hour, the blood sample should be placed in a low-temperature centrifuge for centrifugation.

Conditions

• AUD

Interventions

Type	Name	Description
DRUG	Naltrexone implant	Naltrexone implant
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-06-16
• Primary completion: 2023-12-31
• Completion: 2024-05-01
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: China