Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin

NCT ID: NCT06031454

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-31

Brief Summary

The drug-drug interaction study had been designed to investigate the effect of Leritrelvir on the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and Rifampin on the pharmacokinetics of Leritrelvir

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 × 15-mg Midazolam tablet ,1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet

Period 2: 6 × 400-mg Leritrelvir tablet+1 × 15-mg Midazolam tablet, 1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

oral

Omeprazole

Intervention Type: DRUG

oral

Rosuvastatin

Intervention Type: DRUG

oral

Leritrelvir

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: 1 × 400-mg Leritrelvir tablet

Period 2: 5 × 240-mg verapamil tablet+1 × 400-mg Leritrelvir tablet

Period 3: 8 × 600-mg rifampin capsule +1 × 400-mg Leritrelvir tablet

Group Type: EXPERIMENTAL

Verapamil

Intervention Type: DRUG

oral

Rifampin

Intervention Type: DRUG

oral

Leritrelvir

Intervention Type: DRUG

oral

Interventions

Midazolam

oral

Intervention Type: DRUG

Omeprazole

oral

Intervention Type: DRUG

Rosuvastatin

oral

Intervention Type: DRUG

Verapamil

oral

Intervention Type: DRUG

Rifampin

oral

Intervention Type: DRUG

Leritrelvir

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(Leritrelvir,Midazolam,Omeprazole,Rosuvastatin, Verapamil, and Rifampin) or any component of study medication;

2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 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 Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

RAY1216-23-05

Identifier Type: -

Identifier Source: org_study_id