Drug-Drug Interaction (DDI) Study for TPN171H

Sponsor

Vigonvita Life Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT06090123

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Apr 27, 2020

Actual Study Completion Date :

Sep 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TPN171H and Itraconazole Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.	Drug: TPN171H 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. Drug: Itraconazole 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.
Experimental: TPN171H and Rifampicin Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.	Drug: TPN171H 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. Drug: Rifampicin 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.

Arm

Intervention/Treatment

Experimental: TPN171H and Itraconazole

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

Drug: TPN171H

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.

Drug: Itraconazole

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.

Experimental: TPN171H and Rifampicin

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

Drug: TPN171H

Drug: Rifampicin

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.

Outcome Measures

Primary Outcome Measures

Cmax of TPN171H [48 hours after taking TPN171H]
Maximum Plasma Concentration (Cmax) of TPN171H
AUC of TPN171H [48 hours after taking TPN171H]
Area under the plasma concentration versus time curve (AUC) of TPN171H

Secondary Outcome Measures

Adverse events [Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)]
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
The pharmacokinetic parameters (TPN171H) :Tmax [48 hours after taking TPN171H]
The pharmacokinetic parameters (TPN171H) :Tmax
The pharmacokinetic parameters (TPN171H) :T1/2 [48 hours after taking TPN171H]
The pharmacokinetic parameters (TPN171H) :T1/2
The pharmacokinetic parameters (TPN171H) :CL/F [48 hours after taking TPN171H]
The pharmacokinetic parameters (TPN171H) :CL/F
The pharmacokinetic parameters (TPN171H) :Vz/F [48 hours after taking TPN171H]
The pharmacokinetic parameters (TPN171H) :Vz/F

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

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:

NCT06090123

Other Study ID Numbers:

TPN171H-05

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erectile Dysfunction

Itraconazole

Rifampin

Study Results

No Results Posted as of Oct 19, 2023