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

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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: TPN171H

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPN171H; 5 mg TPN171H tablets，single dose,oral	Drug: TPN171H; 5 mg TPN171H tablets，single dose,oral

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Gangyi Liu, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: TPN171H-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No