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CompletedNCT05905120Updated Jul 27, 2023

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

A Phase 1 interventional study of Toludivenlafaxine hydrochloride sustained-release tablets in Major Depressive Disorder, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Shanghai Mental Health Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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)

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 6 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Those who voluntarily participate in and sign the informed consent form after understanding the purpose, content, process and possible risks of the trial;
  2. Male, aged 18 to 45 years at the time of signing the informed consent form;
  3. Body weight ≥ 50.0 kg and body mass index (BMI) 18.5 \~ 28.0 kg/m2 (including the boundary value) at screening;
  4. 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);
  5. 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

Exclusion Criteria:

  1. 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);
  2. 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;
  3. 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.;
  4. Abnormal vital signs, laboratory tests, 12 electrocardiogram (ECG), MRI (magnetic resonance imaging) examination indicators, judged by the investigator as abnormal and clinically significant;
  5. 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;

  6. 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.);
  7. 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);
  8. 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;
  9. Those who have special requirements for food and cannot abide by the unified diet or have dysphagia;
  10. 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;
  11. 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;
  12. Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blood donation or blood loss ≥ 200 mL within one month;
  13. 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);
  14. Have a history of suitable to participate in the study as judged by the investigator;
  15. Personnel directly related to this clinical trial;
  16. Patients with poor compliance or other problems who are not suitable for participating in this trial in the opinion of the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Toludivenlafaxine hydrochloride sustained-release tablets

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

    Drug: Toludivenlafaxine hydrochloride sustained-release tablets

Interventions

  • DrugToludivenlafaxine hydrochloride sustained-release tablets

    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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, Shanghai 200030, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05905120
Lead sponsor
Shanghai Mental Health Center
Collaborators
Yantai University
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Mar 2, 2023
Primary completion
Jun 30, 2023
Completion
Jul 26, 2023
Last update
Jul 27, 2023

Study contacts

Yifeng SHEN, MD
study director · Shanghai Mental Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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