CTRI/2022/10/046909招募中不适用
A comparative pharmacokinetic study of Leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) of American Regent, Inc. with LUPRON DEPOT® (leuprolide acetate for depot suspension) 30 mg for 4-month (16-weeks) of AbbVie Corporation, 8401 Trans-Canada Highway, St-Laurent, QC H4S 1Z1 in adult male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- To compare the bioavailability of Leuprolide acetate when two leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) injection dosage forms of American Regent, Inc. (Test) and a reference comparator product LUPRON DEPOT® of AbbVie Corporation, St-Laurent, QC H4S 1Z1, Canada are administered to adult prostate cancer patients.
研究概览
简要总结
American Regent, Inc. has developed a generic product of the LUPRON Depot (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. American Regent, Inc. wants to conduct the study to characterize the pharmacokinetic profile of test product in adult.
male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy. In order to assess steady-state bioequivalence.
The study has been designed at a dose of 30 mg (Depot Injection of 30 mg) in line with the applicable USFDA’s Guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Willing and able to provide voluntary informed consent prior commencement of any study-related activities, and the ability to follow protocol requirements
- •Male subjects aged 18 to 75 years (both inclusive) with body mass index (BMI) between 18.00 to 30.00 kg per m2 (both inclusive)
- •Males with histologically or cytologically confirmed carcinoma of the prostate
- •Subjects, newly diagnosed with locally advanced and or metastatic prostate cancer, scheduled to receive their first dose of leuprolide acetate as a part of their standard of care
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Acceptable hematology status: a.
- •Hemoglobin greater than or equal to 9 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per mm3 c.
- •Platelet count greater than or equal to 100,000 cells per mm3
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equal to 2 X ULN b.
- •Bilirubin less than or equal to 1.2 mg per dL d.
- •Alkaline phosphatase less than or equal to 5 x ULN
- •Subjects with HbA1c less than or equal to 7 %
- •Subjects with life expectancy of at least one year at the time of enrolment
- •Subjects who agree to use adequate male contraceptive methods while in the study
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months before screening.
排除标准
- •Subjects will be excluded from the study based on the following criteria:
- •Known hypersensitivity or contraindication to gonadotropin-releasing hormone(GnRH), GnRH agonist or to any of the components of investigational product
- •Prior orchidectomy, hypophysectomy or adrenalectomy
- •Clinical indication of urinary tract obstruction
- •History of any major surgical procedure (including periodontal) within 28 days of dose of investigational product
- •Corrected QT interval [Bazetts formula (QTcB)] greater than 450 msec at screening
- •History or presence of any uncontrolled systemic disease (Ex. cardiovascular disease, hypertension, diabetes mellitus etc.)
- •Known central nervous system (CNS) metastasis
- •Surgical or other non-healing wounds
- •Subjects with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)
- •Subject with history or presence of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumours or subjects who are on concomitant medications that have been associated with convulsions such as bupropion and Selective serotonin reuptake inhibitors (SSRIs)
- •Subjects with positive urine screen for drugs of abuse on day 0
- •Subjects with positive urine alcohol test on day 0
- •Smokers who smoke greater than or equal to 10 cigarettes or equivalent per week
- •History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer)
- •Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), hemoglobin greater than or equal to 9 g per dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0)
- •Participation in any clinical study 90 days prior to receiving the investigational product (IP) of the current study
- •Loss of greater than or equal to 350 mL blood 90 days prior to receiving the IP of the current study
- •Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study, including but not limited to cirrhosis or psychiatric illness per social situations that would limit adherence to study requirements
- •Any other condition(s) which could significantly interfere with protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
- •Subjects with confirmed novel coronavirus infection (COVID-19) or subjects who have taken COVID-19 vaccine within 4 weeks prior to dosing.
结局指标
主要结局
To compare the bioavailability of Leuprolide acetate when two leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) injection dosage forms of American Regent, Inc. (Test) and a reference comparator product LUPRON DEPOT® of AbbVie Corporation, St-Laurent, QC H4S 1Z1, Canada are administered to adult prostate cancer patients.
时间窗: Subjects will report to the study site on Days 4, 8, 15, 22, 29, 36, 43, 57, 71, 85 and 99 of Randomized Study Period for ambulatory, PK and PD blood sample collection and on Day 116, 120, 127, 134, 141, 148, 155, 169, 183, 197 and 211 of Non-randomized Study Period for ambulatory PK and PD blood sample collection.
次要结局
- To monitor the adverse events and to ensure the safety of subjects.(To assess the pharmacodynamics of leuprolide depot injection.)
研究者
研究点 (12)
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