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

NCT05919017 | Unknown Phase 1

• 1 other identifier: ShenzhenSciencare
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

AUD

Outcome Measures

Primary Outcomes (2)

• Cmax

  PK

  168 day

• AUC

  PK

  168 day

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo implant, subcutaneous abdominal implant, single dose, 10 placebo tablets implanted

Drug: Placebo

Naltrexone implant 0.9 g

EXPERIMENTAL

Naltrexone implant, abdominal subcutaneous implantation, single administration, implantation dose is 0.9g (6 naltrexone implants+4 placebo tablets)

Drug: Naltrexone implant

Naltrexone implant 1.5 g

EXPERIMENTAL

Naltrexone implant, abdominal subcutaneous implantation, single dose of 1.5g (10 naltrexone implants)

Drug: Naltrexone implant

Interventions

Naltrexone implant DRUG

Naltrexone implant

Naltrexone implant 0.9 g; Naltrexone implant 1.5 g

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants who meet any of the following criteria cannot be selected for the experiment:
• The researcher determines that participating in this experiment does not comply with the rights and interests of the subjects, or any other circumstances that do not allow the subjects to conduct the study safely;
• Pregnant and reproductive age women with positive pregnancy tests or lactating women, including those who planned to conceive during the study period. Note: Here, women of childbearing age refer to women with fertility. The following criteria must be met, regardless of their sexual orientation or whether they have undergone tubal ligation: 1) have not undergone hysterectomy or bilateral ovariectomy; Or 2) Have not experienced natural menopause for more than 12 consecutive months (i.e., have menstruated at any time during the previous 12 consecutive months);
• Significant abnormalities in liver function (such as AST or ALT exceeding twice the upper limit of normal values) or liver failure (including but not limited to: abdominal fluid accumulation, prolonged prothrombin time, international standard ratio (INR) ≥ 1.7, esophageal varicose disease) or liver and gallbladder ultrasound display results have a significant impact on the judgment of the efficacy and safety of the study drug;
• Suffering from uncontrollable active infectious diseases in clinical practice, such as active hepatitis B (positive for hepatitis B surface antigen (HBsAg) detection and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) copy number\>1000 IU/ml), active hepatitis C (positive for hepatitis C virus antibody and hepatitis C virus (HCV) ribonucleic acid (RNA)), etc;
• A history of congenital hemorrhagic disease (such as hemophilia) or any clinically significant bleeding, or abnormal platelet function, or prothrombin time (PT) exceeding the upper limit of normal values by more than 3 seconds (sec) during coagulation function testing, or platelet count\<50 × 109/L；
• Previous history of severe pancreatitis or severe tremor delirium episodes;
• According to the judgment of the researchers, the subjects have any severe/uncontrollable systemic diseases (such as respiratory, circulatory, digestive, nervous, hematological, urogenital, endocrine system diseases) or mental illnesses (such as severe depression, schizophrenia, bipolar disorder, etc.) or other major diseases that the researchers believe will hinder the provision of informed consent and make participation in the study unsafe Complicating the interpretation of research outcome data or otherwise affecting the achievement of research objectives;
• Hospitalization or surgery may be required during the study period, including planned elective surgery or hospitalization that cannot be postponed;
• According to the DSM-5 standard, currently diagnosed (within one year prior to randomization/administration) with substance use disorders other than alcohol, such as benzodiazepines, amphetamines, opioids, or cocaine;
• Within 30 days before randomization/administration, I have taken drugs to prevent relapse (such as naltrexone) or received systematic psychological support treatment;
• Currently undergoing treatment for opioid, amphetamine, alcohol, and other substance use disorders, or receiving opioid treatment within 7 days before randomization/administration, opioid treatment may be required during the study period, or on the day of randomization/administration, urine opioid, marijuana, amphetamine, and other drugs tested positive or naloxone challenge test positive;
• Allergies to research drugs or their excipients (polylactic acid, magnesium stearate), local anesthetics;
• Participating in any study drug or device research, or having used any study drug or device within 30 days prior to randomization/administration;
• If there is a skin infection or systemic skin disease at the site of implantation surgery, it is determined that it can affect the effectiveness and safety evaluation of the study drug;

Sponsors & Collaborators

• Shenzhen Sciencare Medical Industries Co., Ltd.: lead

Study Sites (1)

Hunan Second People's Hospital

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• zou xuhui, Dr

  Hunan Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zou xuhui, Dr

CONTACT

85232209; ZOUXUHUI@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: June 16, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)