A Clinical Trial of XZP-3287 for Material Balance

NCT05478109 | Unknown Phase 1

• 1 other identifier: XZP-3287-1004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] XZP-3287

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (5)

• PK data for 14C-XZP-3287: Cmax

  Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity

  up to 15 days

• PK data for 14C-XZP-3287: AUClast

  Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity

  up to 15 days

• PK data for 14C-XZP-3287: AUCinf

  Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity

  up to 15 days

• PK data for 14C-XZP-3287: Tmax

  Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity

  up to 15 days

• Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)

  Quantitative analysis of total radioactivity in excreta after oral \[14C\]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways

  up to 15 days

Secondary Outcomes (5)

• Cmax of XZP-3287 in plasma

  up to 15 days

• AUClast of XZP-3287 in plasma

  up to 15 days

• AUCinf of XZP-3287 in plasma

  up to 15 days

• Tmax of XZP-3287 in plasma

  up to 15 days

• To evaluate the safety of [14C] XZP-3287

  up to 29 days

Study Arms (1)

[14C]XZP-3287

EXPERIMENTAL

Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of \[14C\]XZP-3287

Drug: [14C]XZP-3287

Interventions

[14C]XZP-3287 DRUG

360 mg suspension containing 50µCi of \[14C\] XZP-3287

[14C]XZP-3287

Eligibility Criteria

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

You may qualify if:

• Healthy adult males aged 18 to 45 years (inclusive).
• Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
• No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
• No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
• No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
• Subjects are able to communicate well with the investigators, and be able to complete the trial according to the process, and sign an Informed Consent Form.

You may not qualify if:

• Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.
• History of clinically significant ECG abnormalities or family history of long QT syndrome.
• History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
• Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
• Positive results from urine drug screen test.
• Donate blood or lose blood 200 mL or more within 1 month prior to dosing.
• Subjects who have used any medication, herbal medicine, nutritional supplements or health care products within 4 weeks prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.
• History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Gaobo Boren Hospital

Beijing, Beijing Municipality, 100070, China

Location

Central Study Contacts

Cuilan Xiao

CONTACT

+86-13699167610; xiaocuilan@xuanzhubio.com

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: July 18, 2022
• First Posted: July 28, 2022
• Study Start: August 2, 2022
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

CN (1)