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

Phase 1

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: TPN171H

• Registration Number: NCT06090136
• Lead Sponsor: Vigonvita Life Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-14
• Primary Completion: 2020-12-14
• Study Completion: 2022-07-22
• Study First Submitted: 2023-06-21
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. ≥ 65 years old；
2. Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
3. No major organ dysfunction；normal heart, liver and kidney function;
4. 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;
5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent

Exclusion Criteria

1. Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
2. 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
3. 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;
4. Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
5. 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；
6. A history of sudden decrease or loss of hearing；
7. A history of postural hypotension；
8. Blood loss ≥400 mL within 3 months before inclusion；
9. Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
10. 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) ;
11. A history of drug use or have been screened positive for drug abuse;
12. Smoked more than 10 cigarettes a day within 6 months prior to inclusion;
13. hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
14. Other factors that the investigator considered inappropriate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPN171H	TPN171H	5 mg TPN171H tablets，single dose,oral

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, Shanghai, China