Status:
UNKNOWN
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
ALK-POSITIVE NSCLC
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] Ensartinib in healthy Chinese male subjects. The study will be conduct...
Detailed Description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosi...
Eligibility Criteria
Inclusion
- A subject will be eligible for study participation if he meets the following criteria:
- healthy male volunteers between the ages of 18 to 50 years old, inclusive;
- Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others;
- Must understand, and voluntarily sign the informed consent, comply with the requirements of the study
Exclusion
- A subject will not be eligible for study participation if he meets any of the exclusion criteria:
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
- History of clinically significant disease or infection within 1 month before entering the study;
- Abnormality in blood pressure, including hypertensive BP (SBP\>=140 mmHg, or DBP \>=90 mmHg), or hypotensive BP(SBP\<90 mmHg, or DBP \<=55 mmHg), Pulse rate\<55 bpm or \>100 bpm;
- Long-QT syndrome or family history of it, or QTcB interval \> 450 ms; intraventricular blocks or left/right bundle branch block or QRS\>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat \>= 1 in screening period); or abnormal resting heart rate (\> 100 bpm)
- The following abnormal clinical laboratory values
- HGB \< LLN, and is judged as clinically significant by the investigator；
- Abnormal ALP, ALB,TP,CRE,ALT,AST,BIL,BUN, GLU value, and is judged as clinically significant by the investigator;
- Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug or herbal drug, except for vitamins and paracetamol;
- History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
- Hemorrhoids or perianal disease with regular/perianal bleeding;
- Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, hydroxypropyl methylcellulose);
- Have donated 500ml or more of blood or plasma 2 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration;
- Vaccination was administered within 6 months prior to screening or during screening;
- History of drug or alcohol abuse;
- Smoking (\> 10 cigarette / day), drinking (\> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within last 3 months;
- Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
- subject in prison or whose freedom is restricted by administrative or legal issues;
- Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
- Investigator, pharmacist, CRC or research associate;
- Investigators think that subjects are not suitable to participate in the study;
- Subjects who have participated in radiolabeled clinical study prior to drug administration;
- Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations).
Key Trial Info
Start Date :
December 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03804541
Start Date
December 28 2018
End Date
October 1 2019
Last Update
January 15 2019
Active Locations (1)
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1
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu Provence, China, 210005