Clinical trial NCT05942365: A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
Official title: A Phase 1, Open-Label, Two-Period，Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Warfarin
Midazolam
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
2. 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);
3. Ability to understand and willingness to sign a written informed consent form;
4. 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:

1. Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
2. 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;
3. 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;
4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
5. Those with clinically significant ECG abnormalities, or QTcF \> 450ms in men and QTcF \> 470ms in women;
6. 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);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption

Primary outcomes:
measure: S-warfarin Maximum Plasma Concentration [Cmax]
timeFrame: Day1 to Day28
measure: Midazolam Maximum Plasma Concentration [Cmax]
timeFrame: Day1 to Day28
measure: S-warfarin Area under the curve[AUC0-inf]
timeFrame: Day1 to Day28
measure: Midazolam Area under the curve[AUC0-inf]
timeFrame: Day1 to Day28
Secondary outcomes:
measure: Number of participants with adverse events and serious adverse events
timeFrame: Day1 to Day28
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
Study officials:
References: