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Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Toludivenlafaxine hydrochloride sustained-release tablets
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial; Male, aged 18 to 45 years at the time of signing the informed consent form; Body weight ≥ 50.0 kg and body mass index (BMI) 18.5 ~ 28.0 kg/m2 (including the boundary value) at screening; Able to maintain good communication with the investigator and comply with the lifestyle restrictions specified in the protocol and various requirements of the clinical trial (scheduled visits, laboratory tests and other trial procedures); Male subjects and their partners must use effective non-pharmacological contraception (e.g., abstinence and condom with intravaginal spermicide) throughout the study and for 6 months after the end of the study, and must not donate sperm. Exclusion Criteria: Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs); The subject has a current or past medical history judged by the investigator that may affect the clinical trial or dysfunction, including but not limited to a past or present respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and any other clinically significant disease or chronic disease; or any other disease that may interfere with the test results; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.; Abnormal vital signs, laboratory tests, 12 electrocardiogram (ECG), MRI (magnetic resonance imaging) examination indicators, judged by the investigator as abnormal and clinically significant; Use of the following medications or treatments prior to dosing: Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing; Receipt of any contrast agent or radiopharmaceutical within 48 hours prior to, or application of contrast agent within 24 hours after, administration of the trial drug; Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and nerve stimulator in the body, metal foreign body in the body or tracer component allergy, etc.); Any positive result of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and tolulized red unheated serum test (Trust); Smoking habit (an average daily smoking of ≥ 5 cigarettes per day within 3 months before administration), drinking habit (an average weekly drinking of more than 14 standard units within 3 months before administration, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), history of drug abuse or positive results of urine drug screening; Those who have special requirements for food and cannot abide by the unified diet or have dysphagia; Consumption of xanthine-rich foods or beverages (e.g., tea, coffee, cola, or chocolate) or foods or beverages containing grapefruit and/or pomelo within 3 days before dosing; Significant occupational exposure to ionizing radiation (e.g., more than 50 millivolts per year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes within the past 10 years; Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blood donation or blood loss ≥ 200 mL within one month; Those who have participated in other clinical trials within 3 months before administration (including drug and medical device clinical trials, the time is based on the last visit, except for those who have failed screening in other clinical trials and have not received any treatment); Have a history of suitable to participate in the study as judged by the investigator; Personnel directly related to this clinical trial; Patients with poor compliance or other problems who are not suitable for participating in this trial in the opinion of the investigator.

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toludivenlafaxine hydrochloride sustained-release tablets

Arm Description

80 mg/tablet, 2 tablets each time, once a day, for 4 days

Outcomes

Primary Outcome Measures

Percentage of Dopamine Transporters Occupancy in the Basal Ganglia(Positron emission tomography with 11C-CFT was determine by SUVr of the Basal Ganglia DAT) in Human Brain by Toludivenlafaxine Hydrochloride Extended-Release Tablets

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
July 26, 2023
Sponsor
Shanghai Mental Health Center
Collaborators
Yantai University
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1. Study Identification

Unique Protocol Identification Number
NCT05905120
Brief Title
Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
Official Title
A Single-Arm, Non-Randomized, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of Toludivenlafaxine Hydrochloride Extended-Release Tablets Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain Using 11C-CFT Positron Emission Tomography (PET)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Yantai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was a single-arm, non-randomized, open-label clinical study to assess dopamine transporter occupancy in the brain of healthy adults using 11C-CFT positron emission tomography (PET)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toludivenlafaxine hydrochloride sustained-release tablets
Arm Type
Experimental
Arm Description
80 mg/tablet, 2 tablets each time, once a day, for 4 days
Intervention Type
Drug
Intervention Name(s)
Toludivenlafaxine hydrochloride sustained-release tablets
Intervention Description
80 mg/tablet, 2 tablets each time, once a day, for 4 days, orally at 30 min after the start of meals, 200 mL water to take
Primary Outcome Measure Information:
Title
Percentage of Dopamine Transporters Occupancy in the Basal Ganglia(Positron emission tomography with 11C-CFT was determine by SUVr of the Basal Ganglia DAT) in Human Brain by Toludivenlafaxine Hydrochloride Extended-Release Tablets
Time Frame
from baseline to day 4

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial; Male, aged 18 to 45 years at the time of signing the informed consent form; Body weight ≥ 50.0 kg and body mass index (BMI) 18.5 ~ 28.0 kg/m2 (including the boundary value) at screening; Able to maintain good communication with the investigator and comply with the lifestyle restrictions specified in the protocol and various requirements of the clinical trial (scheduled visits, laboratory tests and other trial procedures); Male subjects and their partners must use effective non-pharmacological contraception (e.g., abstinence and condom with intravaginal spermicide) throughout the study and for 6 months after the end of the study, and must not donate sperm. Exclusion Criteria: Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (previous allergy to two or more foods or drugs); The subject has a current or past medical history judged by the investigator that may affect the clinical trial or dysfunction, including but not limited to a past or present respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and any other clinically significant disease or chronic disease; or any other disease that may interfere with the test results; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, etc.; Abnormal vital signs, laboratory tests, 12 electrocardiogram (ECG), MRI (magnetic resonance imaging) examination indicators, judged by the investigator as abnormal and clinically significant; Use of the following medications or treatments prior to dosing: Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing; Receipt of any contrast agent or radiopharmaceutical within 48 hours prior to, or application of contrast agent within 24 hours after, administration of the trial drug; Contraindications to PET or MRI (magnetic resonance imaging) (including claustrophobia, alcohol allergy, cardiac pacemaker and nerve stimulator in the body, metal foreign body in the body or tracer component allergy, etc.); Any positive result of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab) and tolulized red unheated serum test (Trust); Smoking habit (an average daily smoking of ≥ 5 cigarettes per day within 3 months before administration), drinking habit (an average weekly drinking of more than 14 standard units within 3 months before administration, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), history of drug abuse or positive results of urine drug screening; Those who have special requirements for food and cannot abide by the unified diet or have dysphagia; Consumption of xanthine-rich foods or beverages (e.g., tea, coffee, cola, or chocolate) or foods or beverages containing grapefruit and/or pomelo within 3 days before dosing; Significant occupational exposure to ionizing radiation (e.g., more than 50 millivolts per year) or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes within the past 10 years; Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blood donation or blood loss ≥ 200 mL within one month; Those who have participated in other clinical trials within 3 months before administration (including drug and medical device clinical trials, the time is based on the last visit, except for those who have failed screening in other clinical trials and have not received any treatment); Have a history of suitable to participate in the study as judged by the investigator; Personnel directly related to this clinical trial; Patients with poor compliance or other problems who are not suitable for participating in this trial in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifeng SHEN, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

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