Effect of TPN171H on Spermatogenesis
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TPN171H 10mg
TPN171H Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Male aged 18~40years (included)
- Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
- Sperm concentration ≥15*10^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
- Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
- Take reliable contraceptive measures
- Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
- Be able to understand and willing to sign the Informed Consent Form;
Exclusion Criteria:
- People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
- People with vasectomy and ligation
- People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
- There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- A history of fainting needles or fainting blood;
- Blood loss or blood donation of 400 mL or more within 3 months before administration;
- Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
- those who have participated in other drug clinical trials and received trial drugs within 3 months before
- Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
- Urine drug screening positive;
- Smoking more than 10 cigarettes per day ;
- Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- he investigator believes that there are other factors that are not suitable for participating in this trial.
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2
9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2
Outcomes
Primary Outcome Measures
Effect on semen function
The parameters of semen routine analysis were compared between TPN171H tablets and placebo.
Seminal plasma exposure
TPN171H exposure in seminal fluid
Secondary Outcome Measures
Adverse events
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study
Full Information
NCT ID
NCT05585931
First Posted
September 18, 2022
Last Updated
February 19, 2023
Sponsor
Vigonvita Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05585931
Brief Title
Effect of TPN171H on Spermatogenesis
Official Title
Evaluate the Acute Effects of a Single Oral Dose of TPN171H on Semen Function in Healthy Male Subjects in China
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vigonvita Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a phaseⅠstudy to determine the acute effects of TPN171H on semen function in healthy male subjects.
Detailed Description
Safety Study in male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2
Intervention Type
Drug
Intervention Name(s)
TPN171H 10mg
Intervention Description
Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition.
Intervention Type
Drug
Intervention Name(s)
TPN171H Placebo
Intervention Description
Subjects were given Placebo with 240 mL warm water under fasting condition.
Primary Outcome Measure Information:
Title
Effect on semen function
Description
The parameters of semen routine analysis were compared between TPN171H tablets and placebo.
Time Frame
1.5 hours after taking the medicine
Title
Seminal plasma exposure
Description
TPN171H exposure in seminal fluid
Time Frame
1.5 hours after taking the medicine
Secondary Outcome Measure Information:
Title
Adverse events
Description
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study
Time Frame
From administration of study drug through 3 days after last administration of study drug
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male aged 18~40years (included)
Body Mass Index of 19 to 28 kg/m2; Body weight no less than 50 kg;
Sperm concentration ≥15*10^6/ml, Sperm motility(a+b(%))≥32%, Semen volume ≥1.5 ml, Liquefaction time≤60 min
Sperm sample should be collected after a minimum of 2 days and a maximum of 7 days of sexual abstinence.
Take reliable contraceptive measures
Physical examination, vital signs examination, laboratory examination, ECG were normal or abnormal without clinical significance;
Be able to understand and willing to sign the Informed Consent Form;
Exclusion Criteria:
People with azoospermia, teratozoospermia, moderate-to-severe asthenozoospermia, and moderate-to-severe oligozoospermia and other abnormal semen disease
People with vasectomy and ligation
People who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
A history of fainting needles or fainting blood;
Blood loss or blood donation of 400 mL or more within 3 months before administration;
Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration
those who have participated in other drug clinical trials and received trial drugs within 3 months before
Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
Urine drug screening positive;
Smoking more than 10 cigarettes per day ;
Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
he investigator believes that there are other factors that are not suitable for participating in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Jiang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
12. IPD Sharing Statement
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Effect of TPN171H on Spermatogenesis
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