AUDPhase 1NCT05919017
Exploring the PK of Different Doses of Naltrexone in Patients With AUD
A Phase 1 study testing Naltrexone implant in people with AUD, run by Shenzhen Sciencare Medical Industries Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AUD
- What is being tested?
- Naltrexone implant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2023to 1 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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；
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- 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;
- Clinical or laboratory evidence suggests that human immunodeficiency virus (HIV) or syphilis are carried/infected.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Second People's Hospital
Changsha, Hunan, 410011
zou xuhui, Dr, 85232209 ext. 0731, zouxuhui@163.com
About this study
Official title: Exploring the Pharmacokinetic Characteristics of Different Doses of Naltrexone Implants in Patients With Alcohol Use Disorders
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.
Read the 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
- Being tested
- Naltrexone implant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone implantDrug
Naltrexone implant
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo implant, subcutaneous abdominal implant, single dose, 10 placebo tablets implanted Receives: 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) Receives: Drug: Naltrexone implant |
| Naltrexone implant 1.5 g | Experimental | Naltrexone implant, abdominal subcutaneous implantation, single dose of 1.5g (10 naltrexone implants) Receives: Drug: Naltrexone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
PK
Measured: 168 day
AUC
PK
Measured: 168 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start16 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AUDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zou xuhui, Dr, Principal investigator, Hunan Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919017
- Sponsor's protocol ID
- ShenzhenSciencare
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Pharmacokinetic Characteristics of Different Doses of Naltrexone Implants in Patients With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT05919017
- Acronym / sponsor ID
- ShenzhenSciencare
- Conditions
- AUD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo implant, subcutaneous abdominal implant, single dose, 10 placebo tablets implanted |
| Naltrexone implant 0.9 g | Experimental | Drug: Naltrexone implantNaltrexone implant, abdominal subcutaneous implantation, single administration, implantation dose is 0.9g (6 naltrexone implants+4 placebo tablets) |
| Naltrexone implant 1.5 g | Experimental | Drug: Naltrexone implantNaltrexone implant, abdominal subcutaneous implantation, single dose of 1.5g (10 naltrexone implants) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone implantNaltrexone implant | Drug | Naltrexone implant 0.9 g, Naltrexone implant 1.5 g |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cmax
Time frame: 168 day
PK
AUC
Time frame: 168 day
PK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zou xuhui, Dr principal investigator
Hunan Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone implant in people with AUD, run by Shenzhen Sciencare Medical Industries Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zou xuhui, Dr (85232209 ext. 0731, ZOUXUHUI@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 168 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.