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Completed

NCT Number: NCT06090123

Drug-Drug Interaction (DDI) Study for TPN171H

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

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Cmax of TPN171H

    Time frame: 48 hours after taking TPN171H

    Maximum Plasma Concentration (Cmax) of TPN171H

  2. AUC of TPN171H

    Time frame: 48 hours after taking TPN171H

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

Secondary outcomes

  1. 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)

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

  2. The pharmacokinetic parameters (TPN171H) :Tmax

    Time frame: 48 hours after taking TPN171H

    The pharmacokinetic parameters (TPN171H) :Tmax

  3. The pharmacokinetic parameters (TPN171H) :T1/2

    Time frame: 48 hours after taking TPN171H

    The pharmacokinetic parameters (TPN171H) :T1/2

  4. The pharmacokinetic parameters (TPN171H) :CL/F

    Time frame: 48 hours after taking TPN171H

    The pharmacokinetic parameters (TPN171H) :CL/F

  5. The pharmacokinetic parameters (TPN171H) :Vz/F

    Time frame: 48 hours after taking TPN171H

    The pharmacokinetic parameters (TPN171H) :Vz/F

Sponsors and collaborators

Lead sponsor

Vigonvita Life Sciences

Industry

Registry information

Official study title

A Phase 1,Parallel Assignment,Fixed-Sequence Study to Assess the Effect of Itraconazole, Rifampicin on the Pharmacokinetics of TPN171H in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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