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Completed

NCT Number: NCT06090136

Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy 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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TPN171H

Drug

5 mg TPN171H tablets，single dose,oral

Primary outcomes

  1. Adverse events

    Time frame: 7 days after dosing

    Number of Participants With treatment-related Adverse Events and Serious Adverse Events

  2. Pharmacokinetic parameter of TPN171H:Tmax

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:Tmax

  3. Pharmacokinetic parameter of TPN171H:Cmax

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:Cmax

  4. Pharmacokinetic parameter of TPN171H:T1/2

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:T1/2

  5. Pharmacokinetic parameter of TPN171H:AUC0-t

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:AUC0-t

  6. Pharmacokinetic parameter of TPN171H:AUC0-∞

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:AUC0-∞

  7. Pharmacokinetic parameter of TPN171H:AUC0-24h

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:AUC0-24h

  8. Pharmacokinetic parameter of TPN171H:Ke

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:Ke

  9. Pharmacokinetic parameter of TPN171H:Vd

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:Vd

  10. Pharmacokinetic parameter of TPN171H:MRT

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:MRT

  11. Pharmacokinetic parameter of TPN171H:CL/F

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:CL/F

  12. Pharmacokinetic parameter of TPN171H:BRPP

    Time frame: 48 hours after dosing

    Pharmacokinetic parameter of TPN171H:BRPP

Sponsors and collaborators

Lead sponsor

Vigonvita Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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