Last updated: July 26, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Completed
Phase
1
Condition
Depression (Major/severe)
Depression
Affective Disorders
Treatment
Toludivenlafaxine hydrochloride sustained-release tablets
Clinical Study ID
NCT05905120
SMHC-224
Ages 18-45 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Those who voluntarily participate in and sign the informed consent form afterunderstanding 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 theboundary value) at screening;
- Able to maintain good communication with the investigator and comply with thelifestyle restrictions specified in the protocol and various requirements of theclinical 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 andfor 6 months after the end of the study, and must not donate sperm.
Exclusion
Exclusion Criteria:
- Known to have a history of allergy to any component of the investigational product orsimilar drugs, or allergic constitution (previous allergy to two or more foods ordrugs);
- The subject has a current or past medical history judged by the investigator that mayaffect the clinical trial or dysfunction, including but not limited to a past orpresent 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 orchronic 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 thesubjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tractobstruction or dysuria, gastroenteritis, gastrointestinal ulcers, gastrointestinalbleeding, etc.;
- Abnormal vital signs, laboratory tests, 12 electrocardiogram (ECG), MRI (magneticresonance imaging) examination indicators, judged by the investigator as abnormal andclinically significant;
- Use of the following medications or treatments prior to dosing: Use of any prescription medication within 28 days prior to dosing; Use of anyover-the-counter medications, including health products, within 7 days prior todosing; Receipt of any contrast agent or radiopharmaceutical within 48 hours prior to,or application of contrast agent within 24 hours after, administration of the trialdrug;
- Contraindications to PET or MRI (magnetic resonance imaging) (includingclaustrophobia, 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 monthsbefore administration), drinking habit (an average weekly drinking of more than 14standard units within 3 months before administration, 1 unit = 360 mL of beer or 45 mLof 40% spirits or 150 mL of wine), history of drug abuse or positive results of urinedrug screening;
- Those who have special requirements for food and cannot abide by the unified diet orhave dysphagia;
- Consumption of xanthine-rich foods or beverages (e.g., tea, coffee, cola, orchocolate) or foods or beverages containing grapefruit and/or pomelo within 3 daysbefore dosing;
- Significant occupational exposure to ionizing radiation (e.g., more than 50 millivoltsper year) or exposure to radioactive substances or ionizing radiation for therapeuticor research purposes within the past 10 years;
- Blood donation or blood loss ≥ 400 mL within 3 months before administration, or blooddonation or blood loss ≥ 200 mL within one month;
- Those who have participated in other clinical trials within 3 months beforeadministration (including drug and medical device clinical trials, the time is basedon the last visit, except for those who have failed screening in other clinical trialsand 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 participatingin this trial in the opinion of the investigator.
Study Design
Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Toludivenlafaxine hydrochloride sustained-release tablets
Phase: 1
Study Start date:
March 02, 2023
Estimated Completion Date:
July 26, 2023
Connect with a study center
Shanghai Mental Health Center
Shanghai, Shanghai 200030
ChinaSite Not Available

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