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Drug-Drug Interaction (DDI) Study for TPN171H

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TPN171H
Itraconazole
Rifampicin
Sponsored by
Vigonvita Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy male subjects between the ages of 18 and 40 years; Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg; Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance; Take reliable contraceptive measures during the trial and within three months after taking the drug; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements. Exclusion Criteria: Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases; Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension; Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration; A history of postural hypotension; Patients with blood loss ≥400 mL within 3 months before inclusion; Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration; Participated in other drug clinical trials and received trial drugs within 3 months before administration; Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine); Smoking more than 10 cigarettes per day ; Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody; Patients with clinically significant Chest x-ray (posterioranterior) abnormalities; The investigator believes that there are other factors that are not suitable for participating in this trial.

Sites / Locations

  • Shanghai Xuhui Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TPN171H and Itraconazole

TPN171H and Rifampicin

Arm Description

Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.

Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.

Outcomes

Primary Outcome Measures

Cmax of TPN171H
Maximum Plasma Concentration (Cmax) of TPN171H
AUC of TPN171H
Area under the plasma concentration versus time curve (AUC) of TPN171H

Secondary Outcome Measures

Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
The pharmacokinetic parameters (TPN171H) :Tmax
The pharmacokinetic parameters (TPN171H) :Tmax
The pharmacokinetic parameters (TPN171H) :T1/2
The pharmacokinetic parameters (TPN171H) :T1/2
The pharmacokinetic parameters (TPN171H) :CL/F
The pharmacokinetic parameters (TPN171H) :CL/F
The pharmacokinetic parameters (TPN171H) :Vz/F
The pharmacokinetic parameters (TPN171H) :Vz/F

Full Information

First Posted
June 21, 2023
Last Updated
October 17, 2023
Sponsor
Vigonvita Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06090123
Brief Title
Drug-Drug Interaction (DDI) Study for TPN171H
Official Title
A Phase 1,Parallel Assignment,Fixed-Sequence Study to Assess the Effect of Itraconazole, Rifampicin on the Pharmacokinetics of TPN171H in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
September 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vigonvita Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole,cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPN171H and Itraconazole
Arm Type
Experimental
Arm Description
Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
Arm Title
TPN171H and Rifampicin
Arm Type
Experimental
Arm Description
Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Intervention Type
Drug
Intervention Name(s)
TPN171H
Intervention Description
Sequence 1:Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. Sequence 2:Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Description
Sequence 1:Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Intervention Description
Sequence 2:Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Primary Outcome Measure Information:
Title
Cmax of TPN171H
Description
Maximum Plasma Concentration (Cmax) of TPN171H
Time Frame
48 hours after taking TPN171H
Title
AUC of TPN171H
Description
Area under the plasma concentration versus time curve (AUC) of TPN171H
Time Frame
48 hours after taking TPN171H
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Time Frame
Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)
Title
The pharmacokinetic parameters (TPN171H) :Tmax
Description
The pharmacokinetic parameters (TPN171H) :Tmax
Time Frame
48 hours after taking TPN171H
Title
The pharmacokinetic parameters (TPN171H) :T1/2
Description
The pharmacokinetic parameters (TPN171H) :T1/2
Time Frame
48 hours after taking TPN171H
Title
The pharmacokinetic parameters (TPN171H) :CL/F
Description
The pharmacokinetic parameters (TPN171H) :CL/F
Time Frame
48 hours after taking TPN171H
Title
The pharmacokinetic parameters (TPN171H) :Vz/F
Description
The pharmacokinetic parameters (TPN171H) :Vz/F
Time Frame
48 hours after taking TPN171H

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male subjects between the ages of 18 and 40 years; Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg; Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance; Take reliable contraceptive measures during the trial and within three months after taking the drug; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements. Exclusion Criteria: Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases; Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension; Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration; A history of postural hypotension; Patients with blood loss ≥400 mL within 3 months before inclusion; Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration; Participated in other drug clinical trials and received trial drugs within 3 months before administration; Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine); Smoking more than 10 cigarettes per day ; Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody; Patients with clinically significant Chest x-ray (posterioranterior) abnormalities; The investigator believes that there are other factors that are not suitable for participating in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gangyi Liu
Organizational Affiliation
Shanghai Xuhui Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Drug-Drug Interaction (DDI) Study for TPN171H

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