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

NCT05942365 | Completed Phase 1

• 1 other identifier: ZSP1273-23-11
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Drug Interaction; Warfarin; Midazolam

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of participants with adverse events and serious adverse events

  Day1 to Day28

Study Arms (1)

The DDI of ZSP1273 ,Warfarin and Midazolam

EXPERIMENTAL

Warfarin and midazolam will be co-administered alone and in combination with ZSP1273.

Drug: ZSP1273

Interventions

ZSP1273 DRUG

Drug Warfarin oral Drug midazolam oral

The DDI of ZSP1273 ,Warfarin and Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

MeSH Terms

Interventions

ZSP1273

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 12, 2023
• Study Start: June 25, 2023
• Primary Completion: July 21, 2023
• Study Completion: August 4, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CN (1)