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

Phase 1

Recruiting

• Conditions: AUD
• Interventions: Drug: Placebo; Drug: Naltrexone implant

• Registration Number: NCT05919017
• Lead Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-16
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo implant, subcutaneous abdominal implant, single dose, 10 placebo tablets implanted
Naltrexone implant 0.9 g	Naltrexone implant	Naltrexone implant, abdominal subcutaneous implantation, single administration, implantation dose is 0.9g (6 naltrexone implants+4 placebo tablets)
Naltrexone implant 1.5 g	Naltrexone implant	Naltrexone implant, abdominal subcutaneous implantation, single dose of 1.5g (10 naltrexone implants)

Primary Outcome Measures

Name	Time	Method
AUC	168 day	PK
Cmax	168 day	PK

Trial Locations

Locations (1)

Hunan Second People's Hospital; 🇨🇳 Changsha, 湖南省, China