Clinical trial NCT05478109: A Clinical Trial of XZP-3287 for Material Balance
Official title: the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: PK data for 14C-XZP-3287: Cmax
timeFrame: up to 15 days
measure: PK data for 14C-XZP-3287: AUClast
timeFrame: up to 15 days
measure: PK data for 14C-XZP-3287: AUCinf
timeFrame: up to 15 days
measure: PK data for 14C-XZP-3287: Tmax
timeFrame: up to 15 days
measure: Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)
timeFrame: up to 15 days
Secondary outcomes:
measure: Cmax of XZP-3287 in plasma
timeFrame: up to 15 days
measure: AUClast of XZP-3287 in plasma
timeFrame: up to 15 days
measure: AUCinf of XZP-3287 in plasma
timeFrame: up to 15 days
measure: Tmax of XZP-3287 in plasma
timeFrame: up to 15 days
measure: To evaluate the safety of [14C] XZP-3287
timeFrame: up to 29 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Gaobo Boren Hospital
state: Beijing
Study officials:
References: