Study on Human Mass Balance of SPH3127 Tablets

NCT05593562 | Completed Phase 1

• 1 other identifier: SPH3127-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of \[14C\] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of \[14C\]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of \[14C\] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.

Conditions

Primary Mild and Moderate Hypertension

Outcome Measures

Primary Outcomes (3)

• Cumulative excretion rate of total radioactive substances in excreta

  Cumulative excretion rate of total radioactive substances in excreta(urine and faeces).

  240 hours

• The concentration of SPH3127 in plasma

  The concentration of SPH3127 in plasma was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS).

  Sampling performed at predose, and 10 minute,20 minute,0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24,48,72,96,120,144and 168 hours post-dose.

• The total radioactivity in the collected plasma samples

  The total radioactivity in the collected plasma samples was measured directly by liquid scintillation counter.

  up to 168 hours

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Predose and 240 hours post-dose.

Study Arms (1)

SPH3127

EXPERIMENTAL

Oral 100 mg \[14 c\] SPH3127 mixed suspension

Drug: SPH3127

Interventions

SPH3127 DRUG

Oral 100 mg \[14 c\] SPH3127 mixed suspension

SPH3127

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male;
• Age: 18-45 years (inclusive);
• Body weight: the body weight of the subject is ≥ 50 kg, and the body mass index (BMI) is between 19 and 26 kg/m2 (inclusive);
• Subject who fully understands the objective, requirements, content, process and possible adverse reactions of this trial, volunteers for the trial, is able to complete the trial according to the trial requirements and comply with study instructions, and the process of obtaining informed consent conforms to GCP;
• Subject who can communicate well with the investigator and complete the trial according to the protocol.

You may not qualify if:

• Those with clinically significant abnormalities in physical examination, vital signs, laboratory tests, thyroid function, 12-lead ECG, chest CT, abdominal ultrasound and other examinations;
• Those positive for combined detection of hepatitis B surface antigen or e antigen, hepatitis C virus antibody IgG, human immunodeficiency virus antigen/antibody and Treponema pallidum antibody;
• Screening for SARS-COV-2 infection: those with clinically significant abnormalities in C-reactive protein or positive for SARS-COV-2 RNA;
• Those who have used any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening;
• Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements within 14 days prior to screening;
• Those who have a history of any clinical serious disease or any disease or condition that the investigator thinks may affect the trial results, including but not limited to the medical history of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic disorders;
• Those with a personal history or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsades de pointes, ventricular tachycardia, atrioventricular block, prolonged QT syndrome;
• Those who have undergone major surgery or have incomplete healing of surgical incision within 6 months prior to screening; major surgery includes, but is not limited to, any surgery with significant bleeding risk, prolonged general anesthesia, or open biopsy or significant traumatic injury;
• Those with allergic constitution, such as a known history of allergy to two or more substances; or those who, at the investigator's discretion, may be allergic to the investigational drug or its excipients;
• Those with perianal disease, irritable bowel syndrome, inflammatory bowel disease with regular/ongoing hematochezia;
• Those with habitual constipation or diarrhea;
• Those who drink excessively or drink frequently within 6 months prior to screening, that is, drinking more than 14 units of alcohol every week and unable to quit during the trial; or the alcohol breath test result is \> 0 mg/dL during screening period;
• Those who smoke more than 5 cigarettes a day or habitually used nicotine-containing products within three months prior to screening, and are unable to quit during the trial;
• Those who have a history of drug abuse within 3 months prior to screening or have a positive urine test for illegal drugs during screening;
• Those who habitually drink grapefruit juice or excessive tea, coffee and/or caffeinated drinks, and are unable to quit during the trial;

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

SPH3127

Study Design

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

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 25, 2022
• Study Start: October 16, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-10

Locations

CN (1)