A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human

NCT05836805 | Unknown Phase 1

• 1 other identifier: XZP-3621-1004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, metabolism, safety and tolerability of a single oral dose of \[14C\]XZP-3621 in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

[14C]XZP-3621; Mass Balance

Outcome Measures

Primary Outcomes (6)

• Total recovery of radioactivity in urine and feces

  Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.

  Assessments will be made up to 19 days post dose

• Radioactivity concentration of each plasma sample

  Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample

  Assessments will be made up to 19 days post dose

• Metabolic profiling for XZP-3621 will be determined in plasma, urine and fecal samples

  Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

  Assessments will be made up to 19 days post dose

• Maximum exposure in plasma will be determined for XZP-3621, XZP-5089 metabolite and total radioactivity

  Cmax (maximum observed plasma concentration) will be reported directly from each analyte's data

  Assessments will be made up to 19 days post dose

• The overall exposure in plasma will be determined for XZP-3621, metabolite and total radioactivity

  AUC0-∞ (Area under the plasma concentration time profile from time 0 extrapolated to infinite time) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte

  Assessments will be made up to 19 days post dose

• The terminal elimination half life in plasma will be estimated from plasma profiles over time for XZP-3621, metabolite and total radioactivity

  t1/2 (apparent terminal elimination half life) will be estimated for each analyte from the terminal portion of its plasma concentration versus time plot

  Assessments will be made up to 19 days post dose

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Assessments will be made up to 28 days post dose

Study Arms (1)

[14C]XZP-3621

EXPERIMENTAL

Eligible healthy 6 volunteers will receive a single oral dose of 400 mg/200 µCi \[14C\]XZP-3621 administered by mouth, as a suspension solution.

Drug: [14C]XZP-3621

Interventions

[14C]XZP-3621 DRUG

Extemporaneously compounded oral suspension solution of \[14C\]XZP-3621 (400 mg/200 µCi)

[14C]XZP-3621

Eligibility Criteria

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

You may qualify if:

• A subject will be eligible for study participation if he meets the following criteria:
• healthy male volunteers between the ages of 18 to 45 years old, inclusive 18 and 45;
• Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
• 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 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others;
• Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.

You may not qualify if:

• Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the test drug;
• Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start;
• Clinically significant of ophthalmologic examinations;
• Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
• History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
• History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease,Hemorrhoids or perianal disease with regular/perianal bleeding;
• Received major surgery within 6 months prior to the screening period or surgical incisions were not fully healed;
• Smoking (\> 5 cigarette / day), drinking (\> 14 units, pure alcohol / week, equivalent to 360 ml beer/unit, or 45 ml low-alcohol liquor) within 3 months prior to the screening period or Positive screening tests for alcohol,Subjects should avoid smoking and drinking during the clinical trail;
• Participation in an investigational drug or device study within 3 months prior to screening period;
• Subjects who have participated in radiolabeled clinical study within 1 year prior to screening period;
• History of abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within 1 year prior to screening period;
• Have donated 400ml or more of blood or plasma 3 months prior to the study drug administration;
• Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug or herbal drug;
• Use of any metabolic inducers (including herbals such as St. John's Wort) or inhibitors within 14 days before the first dose of study medication;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou Universiy

Suzhou, Jiangsu, 215006, China

Location

Study Officials

• Liyan Miao, DPH

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingfeng Wang

CONTACT

+86-13117522385; wangbingfeng@xuanzhubio.com

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: April 19, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-01

Locations

CN (1)