The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers

NCT04810533 | Completed Phase 1

• 1 other identifier: SHC013-I-04
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (5)

• The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in blood and in total, up to Day 15

  The distribution of \[14C\]SH-1028 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered \[14C\]SH-1028 in healthy male volunteers.

  Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs

• The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in urine, faeces and in total, up to Day 15.

  Quantitive analysis of whole radioactivity of excrement of orally administered \[14C\]SH-1028 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.

  Day1 to Day 15

• The concentrations of SH-1028, Imp2 and Imp3 in plasma up to Day 15

  Quantitive analysis of the concentrations of SH-1028 and Imp2,Imp3 (Metabolites of SH-1028) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.

  Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs

• Proportion of different metabolites

  Proportion of different metabolites in healthy volunteers after oral administration of \[14C\]SH-1028

  Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs

• Types of adverse events

  Types of adverse events assessed by CTCAE v5.0 that occurred during the trial

  Baseline (Day-2) to Day 15

Study Arms (1)

[14C] SH-1028

EXPERIMENTAL

Volunteers will receive 200 mg \[14C\] SH-1028 containing a nominal 88 μCi activity, administered by mouth, as a solution.

Drug: [14C] SH-1028

Interventions

[14C] SH-1028 DRUG

Volunteer will receive a single oral dose of 200 mg/88 uCi \[14C\]SH-1028 as a solution on Day 1

[14C] SH-1028

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers between the age of 18 to 50 years old；
• Body weight \>=50 kg, Body mass index between 19 and 26 kg/m2 (including 19 and 26 kg/m2);
• Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
• Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.;
• Signing the informed consent forms by oneself;
• Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.

You may not qualify if:

• History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
• Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;
• Long-QT syndrome or family history of it, or QTcF interval \> 450 mses;
• Allergies, have allergies to drugs or foods; or have known allergies to the components of the drug;
• Those who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；
• The weekly alcohol consumption was higher than 14 units of alcohol (1 unit=10ml or 8g absolute alcohol. 25 ml 40% liquor, 330ml 5% beers, 175ml 12% grape wine are equal to 1.0, 1.5 and 2.0 units of alcohol respectively) 3 months prior to screening period, or positive test for the alcohol breath test results during screening period；
• Those have history of drug abuse or taking soft drug (i.e., marihuana); or the results of urine test in drugs were positive;
• Participated in other clinical trials within 3 months before screening;
• Received any drug within 14 days before taking the investigational drug;
• Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers- barbiturates, tegretol, phenytoin, rifampicin, hexadecadrol, rifabutin, rifapentini; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, verapamil, imidazoles- antifungal drugs) 30 days prior to screening period；
• History of syncope / needle syncope and intolerable intravenous indwelling needle;
• Those who have undergone major surgery within the first 6 months of the screening period;
• Those who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease；
• Hemorrhoids or perianal disease with regular/perianal bleeding;
• Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations);

Sponsors & Collaborators

• Nanjing Sanhome Pharmaceutical, Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

SH-1028

Study Officials

• Feng Shao, Ph D

  Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

  PRINCIPAL INVESTIGATOR

• Wei Liu, M.A

  Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

  PRINCIPAL INVESTIGATOR

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: March 17, 2021
• First Posted: March 23, 2021
• Study Start: May 13, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)