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Completed

NCT Number: NCT06031454

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

midazolam

Drug

oral

Omeprazole

Drug

oral

Rosuvastatin

Drug

oral

Verapamil

Drug

oral

Rifampin

Drug

oral

Leritrelvir

Drug

oral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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