Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid

NCT ID: NCT05954624

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2023-11-30

Brief Summary

The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273

Conditions

Drug Drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental 1

All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:

Period 1: 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet Period 2: 8 × 600-mg ZSP1273 tablet+1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet

Group Type: EXPERIMENTAL

Digoxin

Intervention Type: DRUG

oral

Rosuvastatin

Intervention Type: DRUG

oral

ZSP1273

Intervention Type: DRUG

oral

Experimental 2

All participants will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:

Period 1: 600-mg ZSP1273 tablet Period 2: 5× 500mg Probenecid tablet BID+600-mg ZSP1273 tablet Period3: （Day1）200mg Itraconazole Capsule BID，（Day2-7）200mg Itraconazole Capsule QD+600-mg ZSP1273 tablet

Group Type: EXPERIMENTAL

ZSP1273

Intervention Type: DRUG

oral

Itraconazole

Intervention Type: DRUG

oral

Probenecid

Intervention Type: DRUG

oral

Interventions

Digoxin

oral

Intervention Type: DRUG

Rosuvastatin

oral

Intervention Type: DRUG

ZSP1273

oral

Intervention Type: DRUG

Itraconazole

oral

Intervention Type: DRUG

Probenecid

oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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);

2. Ability to understand and willingness to sign a written informed consent form;

3. Normal physical examination, vital signs, 12-lead ECG, 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,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;

2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to 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 Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Guangzhou University of Chinese medicine

Guangzhou, , China

Countries

China

Other Identifiers

ZSP1273-23-13

Identifier Type: -

Identifier Source: org_study_id