Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants

NCT05475834 | Completed Phase 1

• 1 other identifier: SIM0417-104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.

Conditions

Healthy Male Volunteers

Keywords

Mass Balance

Outcome Measures

Primary Outcomes (5)

• Total recovery of SIM0417-related substances in urine

  Total recovery of SIM0417-related substances in urine after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)

  Up to 168 hours(approx) from SIM0417 administration

• Total recovery of SIM0417-related substances in feces

  Total recovery of SIM0417-related substances in feces after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)

  Up to 168 hours(approx) from SIM0417 administration

• Identification of metabolites in plasma

  Identification of metabolites in plasma (if applicable), to identification of major biotransformation pathways

  Up to 72 hours (approx) from SIM0417 administration

• Identification of metabolites in urine

  Identification of metabolites in urine (if applicable), to identification of major biotransformation pathways

  Up to 168 hours (approx) from SIM0417 administration

• Identification of metabolites in feces

  Identification of metabolites in feces (if applicable), to identification of major biotransformation pathways

  Up to 168 hours (approx) from SIM0417 administration

Secondary Outcomes (4)

• Adverse Events

  Up to 14 days from SIM0417 administration

• Vital Signs

  Up to 8 days from SIM0417 administration

• ECG

  Up to 8 days from SIM0417 administration

• Laboratory Tests

  Up to 8 days from SIM0417 administration

Study Arms (1)

SIM0417

EXPERIMENTAL

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

Drug: SIM0417

Interventions

SIM0417 DRUG

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

SIM0417

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 subjects aged ≥18 years and ≤55 years old.
• Body weight ≥50 kg, body mass index ≥19 kg/m2 and ≤28 kg/m2.
• Subjects agree to take recognized effective contraceptive measures during the study period and within 3 months after the last dose of the study drug, starting from signing the informed consent.

You may not qualify if:

• 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/metabolism/excretion (including habitual constipation or diarrhea, perianal disease or hematochezia, irritable bowel syndrome, inflammatory bowel disease, etc.).
• Have special requirements for diet and cannot comply with the provided diet 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 ) are allergic to any component of the research drug or research drug.
• Have taken special diet ( including of pitaya, mango, grapefruit, food or beverage containing caffeine, etc. ) or intense exercise within 48 h before the first administration of the drug.
• Any prescription, non-prescription, vitamin, or herbal medicine was taken within 4 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 was 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 be positive in drug abuse screening test.
• At the time of screening, 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, 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

SIM0417

Study Officials

• Wei Zhao

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

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: July 20, 2022
• First Posted: July 27, 2022
• Study Start: July 21, 2022
• Primary Completion: August 7, 2022
• Study Completion: August 7, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)