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

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 1

Conditions: Drug Drug Interaction

Treatments: Drug: ZSP1273; Drug: Probenecid; Drug: Rosuvastatin; Drug: Itraconazole; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05954624

ZSP1273-23-13

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Experimental 1

Experimental group

Description:

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

Treatment:

Drug: ZSP1273

Drug: Rosuvastatin

Drug: Digoxin

Experimental 2

Experimental group

Description:

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

Treatment:

Drug: Probenecid

Drug: ZSP1273

Drug: Itraconazole