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ElderPhase 1NCT05826249

Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects

A Phase 1 study testing SIM0417/Ritonavir in people with Elder, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Elder
What is being tested?
SIM0417/Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
7 Apr 2023to 30 Nov 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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
  • Male and female subjects aged ≥65.
  • Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 19 and ≤ 30 kg/m^2.
  • Subjects of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 1 months after the last dose of the investigational product, starting from signing the informed consent.

Who cannot join

  • Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, skeletal-muscular disorders requiring pharmacological intervention or unstable control, hepatic or renal insufficiency, or any other disease or condition that may affect the results of the study or the safety of the subjects.
  • Difficulty in venous blood collection, a history of fainting blood or needles, or those who cannot tolerate blood collection with intravenousindwelling needles.
  • With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
  • Serious infection, trauma, major surgery, gastrointestinal surgery affecting drug absorption within 4 weeks prior to screening
  • Within six months before screening, patients with myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure ( NYHA II-IV ), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention or clinically significant abnormalities on screening cardiac ultrasound.
  • With blood donation or blood loss was greater than 200 mL within 3 months prior to screening, or blood transfusion or blood products were received within 4 weeks.
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  • 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 investigational product or investigational product.
  • 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 investigational product.
  • CYP3A enzyme/P-gp inducer used within 4 weeks prior to screening, or CYP3A enzyme/P-gp inhibitor used within 2 weeks prior to screening; or a prescription drug, over-the-counter drug, herbal medicine was used within 1 week prior to screening; or any health product such as vitamins used during the screening period.
  • Those who have been vaccinated within 1 month before screening (except for the COVID-19 vaccine), or who plan to be vaccinated during treatment / within 2 weeks after the last dose of investigational product.
  • Participation as a subject in any clinical trial with a research intervention within 3 months prior to screening
  • 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.
  • 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 ≥150 mmHg, diastolic blood pressure <60 mmHg or ≥95 mmHg, pulse <55 bpm or >100 bpm.respiratory rate <12 or >20 breaths/min, SpO2 <95%.
  • Significant abnormalities on ECG at screening (e.g. degree II type II conduction block, left bundle branch block, etc.) QTcF (Fridericia formula) ≥ 470 msec (female)/450 msec (male), or presence of tip-twist Risk factors for ventricular tachycardia (e.g. history of heart failure, family history of prolonged QT interval syndrome)
  • HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening.
  • Blood biochemical test in following ranges at screening: ALT or AST >1.5 x ULN, triglycerides ≥ 2.3 mmol/L (200 mg/dL), total cholesterol ≥ 6.2 mmol/L (240 mg/dL), blood uric acid ≥ 480 μmol/L (8 mg/dL) Absolute eGFR < 90 mL/min ( eGFR = eGFR（CKD-EPI）× BSA / 1.73).
  • Be positive in SARS-CoV-2 nucleic acid or antigen at screening.
  • Be positive in β-hCG at screening(not applicable to postmenopausal female subjects).
  • 21.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.

Juan Wu contact

18920299268

wujuan3@simcere.com

Chen Danny contact

China1 site, 1 recruiting

  • Shandong First Medical University

    Jinan, Shandong, 250014

    Wei Zhao, Doctor, 15131190710, zhao4wei2@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Single Center, Non-randomized, Open-label Phase I Study to Investigate the Pharmacokinetics and Safety of SIM0417/Ritonavir After Single Dose Administration in Healthy Elderly Subjects

This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women.

Read the detailed description

Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dose administration, and ritonavir is administered 12 hours before SIM0417 administration (-12hours), at the time of SIM0417 administration (0hour) and 12hours (12hours), SIM0417 is administered under fasting condition, ritonavir is administered under fasting condition either after meal.

The dose of SIM0417 is 750 mg, and the dose of ritonavir is 100 mg.

Conditions
Elder
Being tested
SIM0417/Ritonavir

What participants receive

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

  • SIM0417/RitonavirDrug

    Also called 750 mg SIM0417/100 mg ritonavir

    Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.

Study groups in NCT05826249
Study groupRoleWhat they receive
SIM0417/RitonavirExperimentalSingle oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.
Receives: Drug: SIM0417/Ritonavir

What is being measured

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

  1. Cmax

    Cmax of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  2. AUC0-t

    AUC0-t of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  3. AUC0-∞

    AUC0-∞ of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  4. Tmax

    Tmax of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  5. t1/2

    t1/2 of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  6. CL/F

    CL/F of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

  7. Vz/F

    Vz/F of SIM0417

    Measured: Up to 72 hours from SIM0417 administration

Secondary outcomes (5)

  1. Adverse Events

    Proportion of adverse events

    Measured: Up to Day 14

  2. Proportion of subjects with abnormal Vital Signs

    Proportion of Participants With Clinically Notable Vital Signs

    Measured: Up to Day 4

  3. Proportion of subjects with abnormal 12-lead electrocardiogram (ECG)

    Proportion of Participants With Clinically Notable ECG

    Measured: Up to Day 4

  4. Proportion of subjects with abnormal Laboratory Tests

    Proportion of Participants With Clinically Notable Laboratory Tests

    Measured: Up to Day 4

  5. Proportion of subjects with abnormal Physical Examination

    Proportion of Participants With Clinically Notable Physical Examination

    Measured: Up to Day 4

Timeline

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

  1. First posted24 Apr 2023
  2. Study start7 Apr 2023
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826249
Sponsor's protocol ID
SIM0417-108
Status last verified
Apr 2023
First submitted
24 Mar 2023
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SIM0417/Ritonavir in people with Elder, run by Jiangsu Simcere Pharmaceutical 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 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: status not confirmed, as of the sponsor's last update on 24 Apr 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juan Wu (18920299268, wujuan3@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Up to 72 hours from SIM0417 administration). The study lists 7 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 NCT05826249.

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 24 Apr 2023.

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