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

• Sponsor: Vigonvita Life Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06090136
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: TPN171H	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study Evaluating Safety and Pharmacokinetics of a Single Oral TPN171H in Elderly Subjects
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Dec 14, 2020
• Actual Study Completion Date: Jul 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse events [7 days after dosing]

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

2. Pharmacokinetic parameter of TPN171H:Tmax [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:Tmax

3. Pharmacokinetic parameter of TPN171H:Cmax [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:Cmax

4. Pharmacokinetic parameter of TPN171H:T1/2 [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:T1/2

5. Pharmacokinetic parameter of TPN171H:AUC0-t [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:AUC0-t

6. Pharmacokinetic parameter of TPN171H:AUC0-∞ [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:AUC0-∞

7. Pharmacokinetic parameter of TPN171H:AUC0-24h [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:AUC0-24h

8. Pharmacokinetic parameter of TPN171H:Ke [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:Ke

9. Pharmacokinetic parameter of TPN171H:Vd [48 hours after dosing]

   Pharmacokinetic parameter of TPN171H:Vd

10. Pharmacokinetic parameter of TPN171H:MRT [48 hours after dosing]

    Pharmacokinetic parameter of TPN171H:MRT

11. Pharmacokinetic parameter of TPN171H:CL/F [48 hours after dosing]

    Pharmacokinetic parameter of TPN171H:CL/F

12. Pharmacokinetic parameter of TPN171H:BRPP [48 hours after dosing]

    Pharmacokinetic parameter of TPN171H:BRPP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Xuhui Central Hospital	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

• Vigonvita Life Sciences

Investigators

• Principal Investigator: Gangyi Liu, Shanghai Xuhui Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vigonvita Life Sciences
• ClinicalTrials.gov Identifier: NCT06090136
• Other Study ID Numbers: TPN171H-06
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Oct 19, 2023