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

NCT06031454 | Completed Phase 1

• 1 other identifier: RAY1216-23-05
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic - Cmax

  Maximum observed plasma concentration

  0-72 hours

• Pharmacokinetic -Area under the curve（AUC）

  Area under the curve

  0-72 hours

Secondary Outcomes (1)

• Number of participants with adverse events

  Day1-Day31

Study Arms (2)

Experimental 1

EXPERIMENTAL

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; Drug: Omeprazole; Drug: Rosuvastatin; Drug: Leritrelvir

Experimental 2

EXPERIMENTAL

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; Drug: Rifampin; Drug: Leritrelvir

Interventions

Midazolam DRUG

oral

Experimental 1

Omeprazole DRUG

oral

Experimental 1

Rosuvastatin DRUG

oral

Experimental 1

Verapamil DRUG

oral

Experimental 2

Rifampin DRUG

oral

Experimental 2

Leritrelvir DRUG

oral

Experimental 1; Experimental 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Midazolam; Omeprazole; Rosuvastatin Calcium; Verapamil; Rifampin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Pyrimidines; Phenethylamines; Ethylamines; Amines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)