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

Drug Drug Interaction Clinical Trial

Official title:

A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05954624
• Other study ID #: ZSP1273-23-13
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 30, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• Digoxin
oral
• Rosuvastatin
oral
• ZSP1273
oral
• Itraconazole
oral
• Probenecid
oral

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou University of Chinese medicine	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	Pharmacokinetic - Cmax	Maximum observed plasma concentration	0-168 hours
Primary	Pharmacokinetic -Area under the curve(AUC)	Area under the curve	0-168 hours
Secondary	Number of participants with adverse events	The safety and tolerability of ZSP1273 alone and in combination with Itraconazole, rosuvastatin, Probenecid and digoxin will be examined.	Day1 to Day30