A Clinical Trial of XZP-3287 for Material Balance

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05478109
• Other study ID #: XZP-3287-1004
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2, 2022
• Est. completion date: January 4, 2023

Study information

• Verified date: July 2022
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: Cuilan Xiao
• Phone: +86-13699167610
• Email: xiaocuilan[@]xuanzhubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• [14C]XZP-3287
360 mg suspension containing 50µCi of [14C] XZP-3287

Locations

Country	Name	City	State
China	Beijing Gaobo Boren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanzhu Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK data for 14C-XZP-3287: Cmax	Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity	up to 15 days
Primary	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
Primary	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
Primary	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
Primary	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	Cmax of XZP-3287 in plasma	Maximum observed concentration for XZP-3287 in plasma	up to 15 days
Secondary	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
Secondary	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
Secondary	Tmax of XZP-3287 in plasma	Time of maximum observed concentration for XZP-3287 in plasma	up to 15 days
Secondary	To evaluate the safety of [14C] XZP-3287	Percentage of Participants with Adverse Events (AEs)	up to 29 days