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Completed

NCT Number: NCT05942365

A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam

This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
  • Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
  • Ability to understand and willingness to sign a written informed consent form;
  • Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion criteria

  • Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
  • Participants with a history of and/or signs and symptoms of current abnormal hemostasis or blood dyscrasia or abnormal prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time at screening;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening,or who cannot stop using any tobacco products during the study period;
  • Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
  • Those with clinically significant ECG abnormalities, or QTcF > 450ms in men and QTcF > 470ms in women;
  • Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
  • Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • History of dysphagia or any gastrointestinal disorder that affect absorption

Treatment and study plan

ZSP1273

Drug

Drug Warfarin oral Drug midazolam oral

Primary outcomes

  1. S-warfarin Maximum Plasma Concentration [Cmax]

    Time frame: Day1 to Day28

    To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin

  2. Midazolam Maximum Plasma Concentration [Cmax]

    Time frame: Day1 to Day28

    To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam

  3. S-warfarin Area under the curve[AUC0-inf]

    Time frame: Day1 to Day28

    To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin

  4. Midazolam Area under the curve[AUC0-inf]

    Time frame: Day1 to Day28

    To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam

Secondary outcomes

  1. Number of participants with adverse events and serious adverse events

    Time frame: Day1 to Day28

    To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Phase 1, Open-Label, Two-Period,Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2023
Registry last updated
Dec 6, 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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