Status:
COMPLETED
Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Drug Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants with a history of hypersensitivity to study drug(Leritrelvir,Midazolam,Omeprazole,Rosuvastatin, Verapamil, and Rifampin) or any component of study medication;
- Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06031454
Start Date
September 1 2023
End Date
December 31 2023
Last Update
April 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China