Drug-Drug Interaction (DDI) Study for TPN171H

NCT06090123 | Completed Phase 1

• 1 other identifier: TPN171H-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• Cmax of TPN171H

  Maximum Plasma Concentration (Cmax) of TPN171H

  48 hours after taking TPN171H

• AUC of TPN171H

  Area under the plasma concentration versus time curve (AUC) of TPN171H

  48 hours after taking TPN171H

Secondary Outcomes (5)

• Adverse events

  Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)

• The pharmacokinetic parameters (TPN171H) :Tmax

  48 hours after taking TPN171H

• The pharmacokinetic parameters (TPN171H) :T1/2

  48 hours after taking TPN171H

• The pharmacokinetic parameters (TPN171H) :CL/F

  48 hours after taking TPN171H

• The pharmacokinetic parameters (TPN171H) :Vz/F

  48 hours after taking TPN171H

Study Arms (2)

TPN171H and Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

TPN171H and Rifampicin

EXPERIMENTAL

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

Interventions

TPN171H DRUG

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.

TPN171H and Itraconazole; TPN171H and Rifampicin

Itraconazole DRUG

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.

TPN171H and Itraconazole

Rifampicin DRUG

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.

TPN171H and Rifampicin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Itraconazole; Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Gangyi Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2020
• Primary Completion: April 27, 2020
• Study Completion: September 2, 2020
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)