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CompletedNCT06031454Updated Apr 16, 2024

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

A Phase 1 interventional study of Midazolam and Omeprazole in Drug Drug Interaction, sponsored by Guangdong Raynovent Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Guangdong Raynovent Biotech Co., Ltd (part of Guangdong Zhongsheng Pharmaceutical Co., Ltd.) · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Drug Drug Interaction
03

In context

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Browse Guangdong Raynovent Biotech Co., Ltd studies →All Guangdong Zhongsheng Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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 · Drug: Omeprazole · Drug: Rosuvastatin · Drug: Leritrelvir

  • 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 · Drug: Rifampin · Drug: Leritrelvir

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic - Cmax

    Maximum observed plasma concentration

    Time frame: 0-72 hours

  2. Pharmacokinetic -Area under the curve（AUC）

    Area under the curve

    Time frame: 0-72 hours

Secondary outcomes

  1. Number of participants with adverse events

    The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined.

    Time frame: Day1-Day31

07

Study locations

1 site
  • the Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
08

References and documents

Publications

  • Peng J, Chen J, Du XX, Li HJ, Qin RZ, Chen SH, Liu X, Cheng Q, Li XM, Huang DX, Duan L, Li MY, Wu WZ, Ye LK, Li YY, Xie ZH, Han K. Pharmacokinetic Drug-Drug Interaction of Leritrelvir in Healthy Chinese Volunteers: A Single-Arm, Open-Label, Dual-Cohort Study. Clin Drug Investig. 2026 Jun;46(6):609-618. doi: 10.1007/s40261-026-01556-w. Epub 2026 May 1. PubMed 42062754 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06031454
Lead sponsor
Guangdong Raynovent Biotech Co., Ltd
Responsible party
Sponsor
First posted
Sep 11, 2023
Start date
Sep 1, 2023
Primary completion
Nov 1, 2023
Completion
Dec 31, 2023
Last update
Apr 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Midazolam · Omeprazole · Rosuvastatin · Verapamil · Rifampin

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