A Clinical Trial of XZP-3287 for Material Balance

Phase 1

• Conditions: Healthy Male Subjects
• Interventions: Drug: [14C]XZP-3287

• Registration Number: NCT05478109
• Lead Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Study Start: 2022-08-02
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PK data for 14C-XZP-3287: Cmax	up to 15 days	Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: AUClast	up to 15 days	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
PK data for 14C-XZP-3287: AUCinf	up to 15 days	Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: Tmax	up to 15 days	Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)	up to 15 days	Quantitative analysis of total radioactivity in excreta after oral \[14C\]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Gaobo Boren Hospital; 🇨🇳 Beijing, Beijing, China