Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects

Study Overview
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Brief Summary
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It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.

Official Title
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A Study Evaluating Safety and Pharmacokinetics of a Single Oral TPN171H in Elderly Subjects

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: TPN171H


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 65 years old； Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)； No major organ dysfunction；normal heart, liver and kidney function; Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent Exclusion Criteria: Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases; Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion; Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。 With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration； A history of sudden decrease or loss of hearing； A history of postural hypotension； Blood loss ≥400 mL within 3 months before inclusion； Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration； Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ; A history of drug use or have been screened positive for drug abuse; Smoked more than 10 cigarettes a day within 6 months prior to inclusion; hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive; Other factors that the investigator considered inappropriate for the study.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPN171H<br>5 mg TPN171H tablets，single dose,oral | Drug: TPN171H<br>* 5 mg TPN171H tablets，single dose,oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of Participants With treatment-related Adverse Events and Serious Adverse Events | 7 days after dosing | 
| Pharmacokinetic parameter of TPN171H:Tmax | Pharmacokinetic parameter of TPN171H:Tmax | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:Cmax | Pharmacokinetic parameter of TPN171H:Cmax | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:T1/2 | Pharmacokinetic parameter of TPN171H:T1/2 | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:AUC0-t | Pharmacokinetic parameter of TPN171H:AUC0-t | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:AUC0-∞ | Pharmacokinetic parameter of TPN171H:AUC0-∞ | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:AUC0-24h | Pharmacokinetic parameter of TPN171H:AUC0-24h | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:Ke | Pharmacokinetic parameter of TPN171H:Ke | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:Vd | Pharmacokinetic parameter of TPN171H:Vd | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:MRT | Pharmacokinetic parameter of TPN171H:MRT | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:CL/F | Pharmacokinetic parameter of TPN171H:CL/F | 48 hours after dosing | 
| Pharmacokinetic parameter of TPN171H:BRPP | Pharmacokinetic parameter of TPN171H:BRPP | 48 hours after dosing |