Healthy VolunteersPhase 1NCT05665647

Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants

A Phase 1 study testing Cohort 1: SIM0417/ritonavir and itraconazole, Cohort 2: SIM0417/ritonavir and rifampicin and Cohort 3: SIM0417/ritonavir and midazolam in people with Healthy Volunteers, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study to evaluate the pharmacokinetic interactions of itraconazole, rifampicin, midazolam, and SIM0417/ritonavir in healthy Chinese subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Cohort 1: SIM0417/ritonavir and itraconazole, Cohort 2: SIM0417/ritonavir and rifampicin and Cohort 3: SIM0417/ritonavir and midazolam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteChina
Study dates: 29 Dec 2022to 14 Feb 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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
Healthy male and female subjects aged ≥18 years and ≤45 years old.
Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2.
Subjects agree to use generally accepted effective contraception from the time they sign the informed consent form. And female subjects of Cohort 1 agree to take recognized effective contraceptive measures during the study period and for the next menstrual cycle after the last dose of the study drug (male subjects up to 1 month after the last dose of the study drug ). Subjects of cohort 2 agree to take recognized effective contraceptive measures during the study period and within 1 month after the last dose of the study drug. Subjects of cohort 3 agree to take recognized effective contraceptive measures during the study period and within 3 months after the last dose of the study drug. Female subjects had been using effective contraception for 14 days prior to screening.

Who cannot join

Any diseases that may affect the study results or the safety and status of the subjects, including but not limited to the central nervous system, respiratory system, cardiovascular system, alimentary system, blood and lymphatic system, endocrine system, musculoskeletal system, hepatic and kidney function obstacle.
Difficulty in venous blood collection, a history of fainting blood or needles, or those who cannot tolerate blood collection with intravenous indwelling needles.
With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
With specific allergic history ( asthma, urticaria, eczema, etc. ) or allergic constitution ( such as those allergic to two or more drugs, food such as milk, and pollen ) or allergic to any component of the research drug or research drug.
With special diet ( including pitaya, mango, grapefruit, food or beverage containing caffeine, etc. ) or intense exercise taken within 48 h before the first administration of the drug.

Show all 22Show fewer

Taken of any prescription, non-prescription, vitamin, or herbal medicine within 4 weeks before and during the screening period and/or any vitamin, health care products were taken within 2 weeks before and during the screening period.
During the first 3 months prior to screening or from the screening period to the first administration period, alcohol was often consumed, i.e., more than 2 units of alcohol per day ( 1 unit = 360 mL beer or 45 mL spirits with 40 % alcohol or 150 mL wine ); or alcohol breath test positive.
More than 5 cigarettes per day during the 3 months prior to screening.
Participated in any drug clinical trial as a subject within 3 months prior to screening and took the study drug.
With blood donation or blood loss greater than 200 mL within 3 months prior to screening, or blood transfusion or blood products were received within 4 weeks.
Have a history of drug abuse or a positive drug abuse screen.
At the time of screening or baseline, the blood pressure in the resting state and the pulse are within the following ranges: such as systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg, pulse <55 bpm or >100 bpm.
Electrocardiographic QTc > 450 msec (Fridericia formula) at screening and/or baseline, or presence of risk factors for Torsade de Pointes (eg, history of heart failure, history of hypokalemia, family with prolonged QT syndrome) history), or other abnormal clinical significance (judged by the investigator).
HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening.
Physical examination, vital signs, ECG, blood routine, blood biochemistry ( serum creatinine, total bilirubin> 1.0 × ULN, ALT, AST, triglyceride>1.1 ULN)), coagulation function, thyroid function, urine routine, chest X-ray, abdominal B-scan ultrasonography results were abnormal and have clinical significance (judged by the investigator).
Those who have been vaccinated within 1 month before screening, or have been vaccinated with a COVID-19 vaccine within 1 week before screening, or plan to be vaccinated during the treatment or within 2 weeks after the last dose of study drug.
Be positive in SARS-CoV-2 nucleic acid test at screening.
Those who had undergone major surgery within 6 months prior to screening or were scheduled to undergo surgery during the study period and were determined by the investigators to be unsuitable for inclusion.
Subjects have acute disease with clinical significance that judged unsuitable for inclusion judged by the investigator within 1 month before screening.
Females who are pregnant or breastfeeding or positive result from pregnancy test.
Subjects have other conditions that are not suitable for participating in this research, or the subjects may not be able to complete this research for other reasons (judged by the investigator).

Trial locations and contacts

1 site in 1 country.

China1 site

Shandong First Medical University
Jinan, Shandong, 250014

Other trials in China

About this study

Official title: An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Adult Chinese Participants

Read the detailed description

This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study which was divided into three cohorts.

Cohort 1: to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SIM0417 and ritonavir in healthy participants.

Cohort 2: to evaluate the effect of the CYP3A4 inducer rifampicin on the pharmacokinetics of SIM0417 and ritonavir in healthy participants.

Cohort 3: to evaluate the effect of SIM0417/ ritonavir on the pharmacokinetics of CYP3A4 substrate midazolam in healthy participants.

Conditions: Healthy Volunteers
Being tested: Cohort 1: SIM0417/ritonavir and itraconazole, Cohort 2: SIM0417/ritonavir and rifampicin, Cohort 3: SIM0417/ritonavir and midazolam
Keywords: Drug-drug interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cohort 1: SIM0417/ritonavir and itraconazoleDrug
Also called Interaction between SIM0417/ritonavir and itraconazole
SIM0417/Ritonavir: Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1-Day2, Day9-Day10, BID; Day3,Day11(once only in the morning); Itraconazole：Dose: 200mg once；Day6-Day13, QD
Cohort 2: SIM0417/ritonavir and rifampicinDrug
Also called Interaction between SIM0417/ritonavir and rifampicin
SIM0417/Ritonavir:Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1,Day11(once only in the morning); Rifampicin：Dose: 0.6g once; Day4-Day12, QD
Cohort 3: SIM0417/ritonavir and midazolamDrug
Also called Interaction between SIM0417/ritonavir and midazolam
SIM0417/Ritonavir: 750 mg SIM0417 coadministered with 100 mg ritonavir, Day3-Day6, BID; Day7(once only in the morning) Midazolam：Dose: 2mg once; Day1, Day6, QD

Study groups in NCT05665647
Study group	Role	What they receive
Cohort 1: SIM0417/ritonavir and itraconazole	Experimental	Interaction between SIM0417/ritonavir and itraconazole Receives: Drug: Cohort 1: SIM0417/ritonavir and itraconazole
Cohort 2: SIM0417/ritonavir and rifampicin	Experimental	Interaction between SIM0417/ritonavir and rifampicin Receives: Drug: Cohort 2: SIM0417/ritonavir and rifampicin
Cohort 3: SIM0417/ritonavir and midazolam	Experimental	Interaction between SIM0417/ritonavir and midazolam Receives: Drug: Cohort 3: SIM0417/ritonavir and midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of SIM0417 in cohort 1
Cmax of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
Ctrough of SIM0417 in cohort 1
Ctrough of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUC0-t of SIM0417 in cohort 1
AUC0-t of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUC0-∞ of SIM0417 in cohort 1
AUC0-∞ of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUCtau of SIM0417 in cohort 1
AUCtau of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
t1/2 of SIM0417 in cohort 1
t1/2 of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
Cmax of SIM0417 in cohort 2
Cmax of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
AUC0-t of SIM0417 in cohort 2
AUC0-t of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
AUC0-∞ of SIM0417 in cohort 2
AUC0-∞ of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
t1/2 of SIM0417 in cohort 2
t1/2 of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
Cmax of midazolam
Cmax of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
Measured: Up to Day 9
AUC0-t of midazolam
AUC0-t of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
Measured: Up to Day 9
AUC0-∞ of midazolam
AUC0-∞ of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
Measured: Up to Day 9
t1/2 of midazolam
t1/2 of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
Measured: Up to Day 9

Secondary outcomes (16)

Adverse Events of Cohort 1
Number of Participants With Adverse Events
Measured: Up to Day 26
Adverse Events of Cohort 2
Number of Participants With Adverse Events
Measured: Up to Day 25
Adverse Events of Cohort 3
Number of Participants With Adverse Events
Measured: Up to Day 20
Vital Signs
Number of Participants With Clinically Notable Vital Signs
Measured: Up to Day 14
ECG
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Measured: Up to Day 14
Laboratory Tests
Number of Participants With Clinically Notable Laboratory Tests
Measured: Up to Day 14
Cmax of ritonavir in Cohort 1
Cmax of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
Ctrough of ritonavir in Cohort 1
Ctrough of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUC0-t of ritonavir in Cohort 1
AUC0-t of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUC0-∞ of ritonavir in Cohort 1
AUC0-∞ of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
AUCtau of ritonavir in Cohort 1
AUCtau of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
t1/2 of ritonavir in Cohort 1
t1/2 of ritonavir when SIM0417/ritonavir is multiple administered or combined with itraconazole
Measured: Up to Day 14
Cmax of ritonavir in Cohort 2
Cmax of ritonavir when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
AUC0-t of ritonavir in Cohort 2
AUC0-t of ritonavir when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
AUC0-∞ of ritonavir in Cohort 2
AUC0-∞ of ritonavir when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14
t1/2 of ritonavir in Cohort 2
t1/2 of ritonavir when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Measured: Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Dec 202214 Feb 2023

First posted27 Dec 2022
Study start29 Dec 2022
Primary completion26 Jan 2023
Study completion14 Feb 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 Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05665647
Sponsor's protocol ID: SIM0417-107
Status last verified: Jan 2023
First submitted: 19 Dec 2022
Last updated: 21 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ye PP, Yao BF, Yang Y, Yang XM, Li Q, Song LL, Chen KG, Zhou HY, Shi JY, Zhang YH, Zhao FR, Guo ZJ, Xu SS, Chen J, Goh AH, Zhu SW, Zheng Y, Zhao W. Drug-drug interactions of simnotrelvir/ritonavir: an open-label, fixed-sequence, two-period clinical trial. Clin Microbiol Infect. 2025 Jan;31(1):101-107. doi: 10.1016/j.cmi.2024.09.007. Epub 2024 Sep 18.
PubMed 39299559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Adult Chinese Participants
ClinicalTrials.gov ID: NCT05665647
Acronym / sponsor ID: SIM0417-107
Conditions: Healthy Volunteers
Keywords: Drug-drug interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Dec 2022 (actual)
Primary completion: 26 Jan 2023 (actual)
Study completion: 14 Feb 2023 (actual)
First posted: 27 Dec 2022 (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.

Detailed description

This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study which was divided into three cohorts.

Cohort 1: to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SIM0417 and ritonavir in healthy participants.

Cohort 2: to evaluate the effect of the CYP3A4 inducer rifampicin on the pharmacokinetics of SIM0417 and ritonavir in healthy participants.

Cohort 3: to evaluate the effect of SIM0417/ ritonavir on the pharmacokinetics of CYP3A4 substrate midazolam in healthy participants.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: SIM0417/ritonavir and itraconazole	Experimental	Drug: Cohort 1: SIM0417/ritonavir and itraconazoleInteraction between SIM0417/ritonavir and itraconazole
Cohort 2: SIM0417/ritonavir and rifampicin	Experimental	Drug: Cohort 2: SIM0417/ritonavir and rifampicinInteraction between SIM0417/ritonavir and rifampicin
Cohort 3: SIM0417/ritonavir and midazolam	Experimental	Drug: Cohort 3: SIM0417/ritonavir and midazolamInteraction between SIM0417/ritonavir and midazolam

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
Healthy male and female subjects aged ≥18 years and ≤45 years old.
Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2.
Subjects agree to use generally accepted effective contraception from the time they sign the informed consent form. And female subjects of Cohort 1 agree to take recognized effective contraceptive measures during the study period and for the next menstrual cycle after the last dose of the study drug (male subjects up to 1 month after the last dose of the study drug ). Subjects of cohort 2 agree to take recognized effective contraceptive measures during the study period and within 1 month after the last dose of the study drug. Subjects of cohort 3 agree to take recognized effective contraceptive measures during the study period and within 3 months after the last dose of the study drug. Female subjects had been using effective contraception for 14 days prior to screening.

Key exclusion criteria (22 listed)

Any diseases that may affect the study results or the safety and status of the subjects, including but not limited to the central nervous system, respiratory system, cardiovascular system, alimentary system, blood and lymphatic system, endocrine system, musculoskeletal system, hepatic and kidney function obstacle.
Difficulty in venous blood collection, a history of fainting blood or needles, or those who cannot tolerate blood collection with intravenous indwelling needles.
With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
With specific allergic history ( asthma, urticaria, eczema, etc. ) or allergic constitution ( such as those allergic to two or more drugs, food such as milk, and pollen ) or allergic to any component of the research drug or research drug.

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
Cohort 1: SIM0417/ritonavir and itraconazoleAlso: Interaction between SIM0417/ritonavir and itraconazoleSIM0417/Ritonavir: Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1-Day2, Day9-Day10, BID; Day3,Day11(once only in the morning); Itraconazole：Dose: 200mg once；Day6-Day13, QD	Drug	Cohort 1: SIM0417/ritonavir and itraconazole
Cohort 2: SIM0417/ritonavir and rifampicinAlso: Interaction between SIM0417/ritonavir and rifampicinSIM0417/Ritonavir:Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1,Day11(once only in the morning); Rifampicin：Dose: 0.6g once; Day4-Day12, QD	Drug	Cohort 2: SIM0417/ritonavir and rifampicin
Cohort 3: SIM0417/ritonavir and midazolamAlso: Interaction between SIM0417/ritonavir and midazolamSIM0417/Ritonavir: 750 mg SIM0417 coadministered with 100 mg ritonavir, Day3-Day6, BID; Day7(once only in the morning) Midazolam：Dose: 2mg once; Day1, Day6, QD	Drug	Cohort 3: SIM0417/ritonavir and midazolam

Primary outcome

Cmax of SIM0417 in cohort 1
Time frame: Up to Day 14
Cmax of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Ctrough of SIM0417 in cohort 1
Time frame: Up to Day 14
Ctrough of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
AUC0-t of SIM0417 in cohort 1
Time frame: Up to Day 14
AUC0-t of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
AUC0-∞ of SIM0417 in cohort 1
Time frame: Up to Day 14
AUC0-∞ of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
AUCtau of SIM0417 in cohort 1
Time frame: Up to Day 14
AUCtau of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
t1/2 of SIM0417 in cohort 1
Time frame: Up to Day 14
t1/2 of SIM0417 when SIM0417/ritonavir is multiple administered or combined with itraconazole
Cmax of SIM0417 in cohort 2
Time frame: Up to Day 14
Cmax of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
AUC0-t of SIM0417 in cohort 2
Time frame: Up to Day 14
AUC0-t of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
AUC0-∞ of SIM0417 in cohort 2
Time frame: Up to Day 14
AUC0-∞ of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
t1/2 of SIM0417 in cohort 2
Time frame: Up to Day 14
t1/2 of SIM0417 when SIM0417/ritonavir is single dosed administration or combined with rifampicin
Cmax of midazolam
Time frame: Up to Day 9
Cmax of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
AUC0-t of midazolam
Time frame: Up to Day 9
AUC0-t of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
AUC0-∞ of midazolam
Time frame: Up to Day 9
AUC0-∞ of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir
t1/2 of midazolam
Time frame: Up to Day 9
t1/2 of midazolam when midazolam is single dosed administration or combined with SIM0417/ritonavir

16 secondary outcomes

Adverse Events of Cohort 1
Time frame: Up to Day 26
Adverse Events of Cohort 2
Time frame: Up to Day 25
Adverse Events of Cohort 3
Time frame: Up to Day 20
Vital Signs
Time frame: Up to Day 14
ECG
Time frame: Up to Day 14
Laboratory Tests
Time frame: Up to Day 14
Cmax of ritonavir in Cohort 1
Time frame: Up to Day 14
Ctrough of ritonavir in Cohort 1
Time frame: Up to Day 14
AUC0-t of ritonavir in Cohort 1
Time frame: Up to Day 14
AUC0-∞ of ritonavir in Cohort 1
Time frame: Up to Day 14
AUCtau of ritonavir in Cohort 1
Time frame: Up to Day 14
t1/2 of ritonavir in Cohort 1
Time frame: Up to Day 14
Cmax of ritonavir in Cohort 2
Time frame: Up to Day 14
AUC0-t of ritonavir in Cohort 2
Time frame: Up to Day 14
AUC0-∞ of ritonavir in Cohort 2
Time frame: Up to Day 14
t1/2 of ritonavir in Cohort 2
Time frame: Up to Day 14

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 21 Feb 2023.
Derived from this study: PubMed 39299559Ye PP, Yao BF, Yang Y, Yang XM, Li Q, Song LL, Chen KG, Zhou HY, Shi JY, Zhang YH, Zhao FR, Guo ZJ, Xu SS, Chen J, Goh AH, Zhu SW, Zheng Y, Zhao W. Drug-drug interactions of simnotrelvir/ritonavir: an open-label, fixed-sequence, two-period clinical trial. Clin Microbiol Infect. 2025 Jan;31(1):101-107. doi: 10.1016/j.cmi.2024.09.007. Epub 2024 Sep 18.
Individual participant dataSharing planned: No

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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.

Wei Zhao principal investigator

Shandong First Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 22 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 21 Feb 2023. 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?

Cmax of SIM0417 in cohort 1 (time frame: Up to Day 14). The study lists 14 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 NCT05665647, 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 21 Feb 2023.