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

• ClinicalTrials.gov Identifier: NCT06031454
• Recruitment Status: Completed
• First Posted: September 11, 2023
• Last Update Posted: April 16, 2024
• Sponsor: Guangdong Raynovent Biotech Co., Ltd
• Information provided by (Responsible Party): Guangdong Raynovent Biotech Co., Ltd

Study Description

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

Condition or disease	Intervention/treatment	Phase
Drug Drug Interaction	Drug: Midazolam; Drug: Omeprazole; Drug: Rosuvastatin; Drug: Verapamil; Drug: Rifampin; Drug: Leritrelvir	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of Leritrelvir With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin in Healthy Participants
• Actual Study Start Date: September 1, 2023
• Actual Primary Completion Date: November 1, 2023
• Actual Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Midazolam; oral; Drug: Omeprazole; oral; Drug: Rosuvastatin; oral; Drug: Leritrelvir; oral
Experimental: 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	Drug: Verapamil; oral; Drug: Rifampin; oral; Drug: Leritrelvir; oral

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic - Cmax [ Time Frame: 0-72 hours ]
   Maximum observed plasma concentration
2. Pharmacokinetic -Area under the curve（AUC） [ Time Frame: 0-72 hours ]
   Area under the curve

Secondary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: Day1-Day31 ]
   The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

China, Guangdong

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Sponsors and Collaborators

Guangdong Raynovent Biotech Co., Ltd

More Information

• Responsible Party: Guangdong Raynovent Biotech Co., Ltd
• ClinicalTrials.gov Identifier: NCT06031454
• Other Study ID Numbers: RAY1216-23-05
• First Posted: September 11, 2023
• Last Update Posted: April 16, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rifampin; Verapamil; Midazolam; Omeprazole; Rosuvastatin Calcium; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents