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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05942365
Other study ID # ZSP1273-23-11
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 25, 2023
Est. completion date August 4, 2023

Study information

Verified date November 2023
Source Guangdong Raynovent Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 4, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZSP1273
Drug Warfarin oral Drug midazolam oral

Locations

Country Name City State
China the Second Affiliated Hospital of Guangzhou Medical University Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary S-warfarin Maximum Plasma Concentration [Cmax] To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin Day1 to Day28
Primary Midazolam Maximum Plasma Concentration [Cmax] To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam Day1 to Day28
Primary S-warfarin Area under the curve[AUC0-inf] To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin Day1 to Day28
Primary Midazolam Area under the curve[AUC0-inf] To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam Day1 to Day28
Secondary Number of participants with adverse events and serious adverse events To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates Day1 to Day28
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