Clinical trial NCT05369858: A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
Official title: A Phase I Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] SKLB1028.


Eligibility criteria: Inclusion Criteria:

* 1. Chinese male subjects aged 18 to 40 years (inclusive), with normal bowel movements (1\~2 times a day).

  2. A minimum body weight of 50 kg and a body mass index ranging from 19 to 26 kg/m\^2 (inclusive).

  3. The male subjects with fertility have no child rearing plan or sperm donation plan with their sexual partners during the trial and within one year after taking the drug, and could take reliable contraceptive measures.

  4. Physical examination, vital signs, laboratory (blood routine, blood biochemistry, coagulation function, urine routine, stool routine and occult blood, etc.), 12 lead ECG, chest X-ray and other tests are normal or abnormal without clinical significance.

  5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.

Exclusion Criteria:

* 1. Subjects with allergies or allergic diseases, or allergy to test preparations, any of their ingredients and food, or subjects with special dietary requirements, who can not follow the uniform diet.

  2. Inability to swallow oral medications or presence of diseases that affect absorption, distribution, metabolism, or excretion of study medication, as well as the evaluation of drug efficacy and safety, such as hemorrhoids or perianal diseases with regular/ongoing stool blood, habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, etc.

  3. History of gastrointestinal ulcer, bleeding, or clinically significant disease, including but not limited to circulatory, endocrine, nervous, digestive, urinary or blood, immune, mental, or metabolic diseases.

  4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum antibody results within 1 month prior to dosing.

  5. Use of any drug that inhibits or induces liver drug-metabolizing enzymes (inducers-barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine, glucocorticoid, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals, sedatives and hypnotics, fluoroquinolones, antihistamines, etc.) within 30 days prior to dosing.

  6. Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days 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.

  7. Presence of major surgery or incomplete healing of surgical incision, including but not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, biopsy or significant traumatic injury within 6 months prior to dosing.

  8. History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection.

  9. Presence of alcohol abuse or regular use of alcohol within 6 months prior to dosing, i.e. weekly alcohol intake of more than 21 units (One unit is equivalent to 360 mL beer, 45 mL spirits containing 40% alcohol or 150 mL wine) or a positive urine or breath alcohol test at screening.

  10. Smoking more than 10 cigarettes a day. 11. Presence or history of drug abuse or use of soft drugs (e.g. cannabis) within 3 months prior to dosing, or use of hard drugs (such as cocaine, amphetamine, phencyclidine, etc.) within the 3 months prior to dosing, or positive urine test for drugs of abuse at screening.

  12. Habitual consumption of grapefruit juice or excessive drink (\>8 cups per day, 1 cup =250 mL) containing caffeine, including coffee, tea.

  13. Workers who need to be exposed to radioactive conditions for a long time; or have radiation exposure (more than 2 chest/abdominal CT, or more than 3 other types of X-ray examinations) within 1 year prior to dosing or participated in clinical studies of radiopharmaceuticals.

  14. Blood loss or donation of one or more units of blood (400 mL) within 3 months prior to the first dose of study medication, or receive blood transfusion within 1 month.

  15. Not suitable for this study as judged by the investigator for any other reason

Primary outcomes:
measure: Cmax
timeFrame: From time zero up to 144 hours post-dose
measure: Tmax
timeFrame: From time zero up to 144 hours post-dose
measure: AUC0-t
timeFrame: From time zero up to 144 hours post-dose
measure: AUC0-∞
timeFrame: From time zero up to 144 hours post-dose
measure: Total radioactivity in urine and faces
timeFrame: From time zero up to 240 hours post-dose
Secondary outcomes:
measure: Number of subjects with treatment-related adverse events
timeFrame: Up to approximately 14 days after dosing
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: