A Clinical Trial of XZP-3287 for Material Balance

the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: [14C]XZP-3287

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cuilan Xiao; Phone Number: +86-13699167610; Email: xiaocuilan@xuanzhubio.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Gaobo Boren Hospital
      • Contact: Fang Hou; Phone Number: 856 +86-10-83605200; Email: houf@gobroadhealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy adult males aged 18 to 45 years (inclusive).
2. Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
3. No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
4. No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
5. No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
6. 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.

Exclusion Criteria:

1. 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.
2. History of clinically significant ECG abnormalities or family history of long QT syndrome.
3. History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
4. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
5. Positive results from urine drug screen test.
6. Donate blood or lose blood 200 mL or more within 1 month prior to dosing.
7. 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.
8. History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]XZP-3287; Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287	Drug: [14C]XZP-3287; 360 mg suspension containing 50µCi of [14C] XZP-3287

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of XZP-3287 in plasma	Maximum observed concentration for XZP-3287 in plasma	up to 15 days
AUClast of XZP-3287 in plasma	Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma	up to 15 days
AUCinf of XZP-3287 in plasma	Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma	up to 15 days
Tmax of XZP-3287 in plasma	Time of maximum observed concentration for XZP-3287 in plasma	up to 15 days
To evaluate the safety of [14C] XZP-3287	Percentage of Participants with Adverse Events (AEs)	up to 29 days

Collaborators and Investigators

• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 2, 2022
• Primary Completion (Anticipated): January 4, 2023
• Study Completion (Anticipated): January 4, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: XZP-3287-1004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No