Drug Drug InteractionPhase 1NCT06031454
Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin
A Phase 1 study testing Midazolam, Omeprazole and Rosuvastatin in people with Drug Drug Interaction, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Midazolam, Omeprazole and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
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
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
- Being tested
- Midazolam, Omeprazole, Rosuvastatin, Verapamil, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
oral
OmeprazoleDrug
oral
RosuvastatinDrug
oral
VerapamilDrug
oral
RifampinDrug
oral
LeritrelvirDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Verapamil; Drug: Rifampin; Drug: Leritrelvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - Cmax
Maximum observed plasma concentration
Measured: 0-72 hours
Pharmacokinetic -Area under the curve（AUC）
Area under the curve
Measured: 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.
Measured: Day1-Day31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031454
- Sponsor's protocol ID
- RAY1216-23-05
- Status last verified
- Apr 2024
- First submitted
- 4 Sep 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06031454
- Acronym / sponsor ID
- RAY1216-23-05
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: Midazolam, Drug: Omeprazole, Drug: Rosuvastatin, Drug: LeritrelvirAll 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 |
| Experimental 2 | Experimental | Drug: Verapamil, Drug: Rifampin, Drug: LeritrelvirAll 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolamoral | Drug | Experimental 1 |
| Omeprazoleoral | Drug | Experimental 1 |
| Rosuvastatinoral | Drug | Experimental 1 |
| Verapamiloral | Drug | Experimental 2 |
| Rifampinoral | Drug | Experimental 2 |
| Leritrelviroral | Drug | Experimental 1, Experimental 2 |
Primary outcome
Pharmacokinetic - Cmax
Time frame: 0-72 hours
Maximum observed plasma concentration
Pharmacokinetic -Area under the curve（AUC）
Time frame: 0-72 hours
Area under the curve
1 secondary outcome
Number of participants with adverse events
Time frame: Day1-Day31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 42062754Peng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam, Omeprazole and Rosuvastatin in people with Drug Drug Interaction, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic - Cmax (time frame: 0-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.