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

NCT05954624 | Completed Phase 1

• 1 other identifier: ZSP1273-23-13
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic - Cmax

  Maximum observed plasma concentration

  0-168 hours

• Pharmacokinetic -Area under the curve（AUC）

  Area under the curve

  0-168 hours

Secondary Outcomes (1)

• Number of participants with adverse events

  Day1 to Day30

Study Arms (2)

Experimental 1

EXPERIMENTAL

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

Drug: Digoxin; Drug: Rosuvastatin; Drug: ZSP1273

Experimental 2

EXPERIMENTAL

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

Drug: ZSP1273; Drug: Itraconazole; Drug: Probenecid

Interventions

Digoxin DRUG

oral

Experimental 1

Rosuvastatin DRUG

oral

Experimental 1

ZSP1273 DRUG

oral

Experimental 1; Experimental 2

Itraconazole DRUG

oral

Experimental 2

Probenecid DRUG

oral

Experimental 2

Eligibility Criteria

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

You may qualify if:

• 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, 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,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;
• Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to 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 Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
• 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 First Affiliated Hospital of Guangzhou University of Chinese medicine

Guangzhou, China

Location

MeSH Terms

Interventions

Digoxin; Rosuvastatin Calcium; ZSP1273; Itraconazole; Probenecid

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Azoles; Piperazines

Study Design

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

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 20, 2023
• Study Start: July 10, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (1)