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

Drug Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05942365
• Other study ID #: ZSP1273-23-11
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Drug Drug Interaction
• Midazolam
• Warfarin

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