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Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03931668
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Kanion Pharmaceutical
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.

Condition or disease Intervention/treatment Phase
PHA1A Drug: TPN-672 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Single Site, Randomized, Double-blind, Placebo-controlled, Incremental Phase I Clinical Trial: to Evaluate the Tolerance, PK and PD Effects of TPN-672 Maleate in Chinese Healthy Volunteers After Single Dose Administration.
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : October 17, 2019
Estimated Study Completion Date : February 17, 2020

Arm Intervention/treatment
Experimental: 0.125mg single dose
single dose of TPN-672 0.125mg, 2 subjects
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 0.25mg single dose
single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 0.5mg single dose
single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 1mg single dose
single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 2mg single dose
single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 3mg single dose
single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet

Experimental: 4mg single dose
single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo)
Drug: TPN-672
single dose of TPN-672 maleate tablet
Other Name: TPN-672 maleate tablet




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 48 hours ]
    Number of Subjects with adverse events during clinical trial

  2. Cmax [ Time Frame: 48 hours ]
    Maximum Plasma Concentration

  3. AUC [ Time Frame: 48 hours ]
    Area Under the Curve

  4. Tmax [ Time Frame: 48 hours ]
    Time to Cmax

  5. T1/2 [ Time Frame: 48 hours ]
    Time of half life

  6. ACR [ Time Frame: 48 hours ]
    Apparent Clearance Rate

  7. ADV [ Time Frame: 48 hours ]
    Apparent Distribution Volume


Secondary Outcome Measures :
  1. prolactin [ Time Frame: 48 hours ]
    serum prolactin test

  2. temperature [ Time Frame: 48 hours ]
    ear temperature

  3. pulse rate [ Time Frame: 48 hours ]
    pulse rate

  4. respiratory [ Time Frame: 48 hours ]
    frequency of respiratory per minute

  5. blood pressure [ Time Frame: 48 hours ]
    lying blood pressure, systolic and diastolic

  6. electrocardiogram(ECG) [ Time Frame: 48 hours ]
    the number of subjects with abnormal ECG report by 12-lead electrocardiogram

  7. QTc [ Time Frame: 48 hours ]
    QTc interval

  8. Extrapyramidal symptoms [ Time Frame: 48 hours ]
    Simpson Angus Rating Scale (SAS), total score ranges from 0 to 40, of which lower values represent a better outcome.

  9. Involuntary Movement [ Time Frame: 48 hours ]
    Abnormal Involuntary Movement Scale (AIMS), total score ranges from 0 to 14, of which lower values represent a better outcome.

  10. Akathisia [ Time Frame: 48 hours ]
    Barnes Akathisia Rating Scale (BARS), total score ranges from 0 to 40, of which lower values represent a better outcome.

  11. IL-6 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-6

  12. IL-4 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-4

  13. IL-1 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-1

  14. IL-2 [ Time Frame: 48 hours ]
    Serum concentration of Interleukin-2

  15. INF-gamma [ Time Frame: 48 hours ]
    Serum concentration of Interferon-gamma

  16. TNF-alpha [ Time Frame: 48 hours ]
    Serum concentration of Tumor necrosis factor-alpha

  17. 5-HT [ Time Frame: 48 hours ]
    Serum concentration of serotonin

  18. DA [ Time Frame: 48 hours ]
    Serum concentration of Dopamine

  19. NE [ Time Frame: 48 hours ]
    Serum concentration of Norepinephrine

  20. BDNF [ Time Frame: 48 hours ]
    Serum concentration of Brain-derived neurotrophic factor

  21. Glutamic acid [ Time Frame: 48 hours ]
    Serum concentration of Glutamic acid

  22. GABA [ Time Frame: 48 hours ]
    Serum concentration of gamma-aminobutyric acid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight > 50kg(male) or > 45kg(female), 19 <BMI<26 kg/m2.
  • Good communication with investigators, willingness and ability to abide by the lifestyle restrictions stipulated in clinical trial
  • Women or men within childbearing age do not have a fertility plan within 3 months after the end of the trial, and agree to adopt contraceptive measures approved (such as intrauterine device, condom, sperm killing gel, condom, uterine cap, etc.) throughout the clinical trial period.
  • Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, can complete the entire trial process according to the requirements of the trial.

Exclusion Criteria:

  • Investigator determined that there were diseases or functional disorders affecting clinical trials, including, but not limited to, central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system.
  • Mental illness or previous history of mental illness;
  • Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc.
  • Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
  • Any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism and excretion, or that may pose a hazard to the subjects participating in the study, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.
  • Those who are known to have a history of drug allergy, allergic disease or allergic constitution of the tested drug ingredients or similar drugs;
  • Smokers who smoked more than 10 cigarettes or the same amount of tobacco per day in the first year of screening;
  • Alcohol addiction within 1 year before screening, with an average weekly alcohol intake of more than 14 units (1 unit = 285 ml beer or 25 ml spirits or 150 ml wine) or positive alcohol breath test;
  • Those who had a history of drug abuse or drug abuse within 1 year before screening, or those who had positive urinary drug screening;
  • Physical examination, current medical history and vital signs were found to be abnormal by researchers and have clinical significance.
  • Resting pulse rate < 55/min or > 100/min; systolic pressure < 90 mmHg or > 140 mmHg, diastolic pressure < 60 mmHg or > 90 mmHg;
  • 12-lead electrocardiogram (ECG) examination was found to be abnormal by investigator and had clinical significance; or the following ECG abnormalities occurred: PR interval > 220 ms, QRS complex wave duration > 120 ms, long QT syndrome (QTc > 450 ms);
  • Family history of sudden cardiac death (less than 40 years old);
  • Abnormal blood routine examination and urine routine examination have clinical significance.
  • Aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr), urea nitrogen (BUN) exceeded the normal upper limit.
  • HBsAg, HCV-Ab, HIV-Ab and TRUST positive patients;
  • Pregnant or lactating women or male subjects whose spouses have child-rearing plans within three months;
  • Those who took any medicine within 2 weeks before admission, including prescription and non-prescription drugs;
  • Blood donation or blood loss (> 200 ml) within 3 months before admission, or a history of using blood products;
  • Participated in any clinical trials within 3 months before admission;
  • Those who had a history of operation within 3 months before admission, or who had not recovered from the operation, or who had anticipated operation plan during the trial period;
  • Do not agree to abide by the following conditions during the experiment: prohibit the use of tobacco, alcohol or caffeine-containing beverages, avoid strenuous exercise;
  • Personnel directly related to this clinical trial;
  • Investigator believes that other subjects are not suitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931668


Contacts
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Contact: Yifeng SHEN, MD PhD 86-21-34773657 shenyifeng@yahoo.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Huafang LI, MD PhD    86-21-34773107    lhlh_5@163.com   
Principal Investigator: Huafang LI, MD PhD         
Sponsors and Collaborators
Shanghai Mental Health Center
Kanion Pharmaceutical
Investigators
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Study Director: Yifeng SHEN, MD PhD Shanghai Mental Health Center

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03931668     History of Changes
Other Study ID Numbers: SMHC-180
TPN672-KYHY-201801 ( Other Identifier: Kanion Pharmaceutical )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Mental Health Center:
tolerance
pharmacokinetics
pharmacodynamics
TPN-672

Additional relevant MeSH terms:
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Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action