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

NCT05826249 | Unknown Phase 1

• 1 other identifier: SIM0417-108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elder

Outcome Measures

Primary Outcomes (7)

• Cmax

  Cmax of SIM0417

  Up to 72 hours from SIM0417 administration

• AUC0-t

  AUC0-t of SIM0417

  Up to 72 hours from SIM0417 administration

• AUC0-∞

  AUC0-∞ of SIM0417

  Up to 72 hours from SIM0417 administration

• Tmax

  Tmax of SIM0417

  Up to 72 hours from SIM0417 administration

• t1/2

  t1/2 of SIM0417

  Up to 72 hours from SIM0417 administration

• CL/F

  CL/F of SIM0417

  Up to 72 hours from SIM0417 administration

• Vz/F

  Vz/F of SIM0417

  Up to 72 hours from SIM0417 administration

Secondary Outcomes (5)

• Adverse Events

  Up to Day 14

• Proportion of subjects with abnormal Vital Signs

  Up to Day 4

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

  Up to Day 4

• Proportion of subjects with abnormal Laboratory Tests

  Up to Day 4

• Proportion of subjects with abnormal Physical Examination

  Up to Day 4

Study Arms (1)

SIM0417/Ritonavir

EXPERIMENTAL

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

Drug: SIM0417/Ritonavir

Interventions

SIM0417/Ritonavir DRUG

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

Also known as: 750 mg SIM0417/100 mg ritonavir

SIM0417/Ritonavir

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

SIM0417; Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wei Zhao

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Wu

CONTACT

18920299268; wujuan3@simcere.com

Chen Danny

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: April 7, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)