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

NCT ID: NCT06090136

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2022-07-22

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPN171H

5 mg TPN171H tablets，single dose,oral

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

5 mg TPN171H tablets，single dose,oral

Interventions

TPN171H

5 mg TPN171H tablets，single dose,oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gangyi Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui Central Hospital

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

TPN171H-06

Identifier Type: -

Identifier Source: org_study_id