Major Depressive DisorderPhase 1NCT05905120
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 study testing Toludivenlafaxine hydrochloride sustained-release tablets in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Toludivenlafaxine hydrochloride sustained-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2023to 26 Jul 2023
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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)
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)
- Conditions
- Major Depressive Disorder
- Being tested
- Toludivenlafaxine hydrochloride sustained-release tablets
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toludivenlafaxine hydrochloride sustained-release tabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Toludivenlafaxine hydrochloride sustained-release tablets | Experimental | 80 mg/tablet, 2 tablets each time, once a day, for 4 days Receives: Drug: Toludivenlafaxine hydrochloride sustained-release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start2 Mar 2023
- Primary completion30 Jun 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yantai University
- Responsible party
- Sponsor
- Investigators
- Yifeng SHEN, MD, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905120
- Sponsor's protocol ID
- SMHC-224
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 27 Jul 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05905120
- Acronym / sponsor ID
- SMHC-224
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Yantai University
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 15 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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toludivenlafaxine hydrochloride sustained-release tablets | Experimental | Drug: Toludivenlafaxine hydrochloride sustained-release tablets80 mg/tablet, 2 tablets each time, once a day, for 4 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
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 |
|---|---|---|
| Toludivenlafaxine hydrochloride sustained-release tablets80 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 | Drug | Toludivenlafaxine hydrochloride sustained-release tablets |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
Yifeng SHEN, MD study director
Shanghai Mental Health Center
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 Toludivenlafaxine hydrochloride sustained-release tablets in people with Major Depressive Disorder, run by Shanghai Mental Health Center 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 27 Jul 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 27 Jul 2023.