Drug-Drug Interaction (DDI) Study for TPN171H

NCT ID: NCT06090123

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-09-02

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: 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.

Itraconazole

Intervention Type: 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 Rifampicin

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

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: 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.

Rifampicin

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects between the ages of 18 and 40 years;

2. Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;

3. Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance;

4. Take reliable contraceptive measures during the trial and within three months after taking the drug;

5. 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

1. Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;

2. 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;

3. 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;

4. A history of postural hypotension;

5. Patients with blood loss ≥400 mL within 3 months before inclusion;

6. Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration;

7. Participated in other drug clinical trials and received trial drugs within 3 months before administration;

8. 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);

9. Smoking more than 10 cigarettes per day ;

10. Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;

11. Patients with clinically significant Chest x-ray (posterioranterior) abnormalities;

12. The investigator believes that there are other factors that are not suitable for participating in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gangyi Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui Central Hospital

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

TPN171H-05

Identifier Type: -

Identifier Source: org_study_id