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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06031454
Enrollment
56
Registered
2023-09-11
Start date
2023-09-01
Completion date
2023-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interaction

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

Interventions

DRUGMidazolam

oral

DRUGOmeprazole

oral

DRUGRosuvastatin

oral

DRUGVerapamil

oral

DRUGRifampin

oral

DRUGLeritrelvir

oral

Sponsors

Guangdong Raynovent Biotech Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetic - Cmax0-72 hoursMaximum observed plasma concentration
Pharmacokinetic -Area under the curve（AUC）0-72 hoursArea under the curve

Secondary

MeasureTime frameDescription
Number of participants with adverse eventsDay1-Day31The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026