NCT03029533Unknown1 期
An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 44 人开始时间: 2017年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥19 and ≤80 years of age at Screening.
- •Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy
- •An ECOG performance status grade of 0 to 2,
- •19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.
排除标准
- •Confirmed Hormone refractory prostate cancer(HRPC)
- •Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy.
- •Diagnosed pituitary adenoma
- •Has a history of depression
- •Has a risk of spinal cor d compression due to metastatic spinal cord injury.
- •Has a severe urethratresia.
- •Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening.
- •Has a history of MI or any procedure with regard to coronary artery disease within 6 months of Screening. (e.g., balloon angioplasty, coronary artery bypass graft)
- •Has any severe concomitant disease that would interfere with the conduct of the study except for prostate cancer
- •Has allergy history of leuprolide acetate, similar GnRH drugs or other medications (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment.
- •Has received an investigational drug within 9 0days of Screening.
- •Drug releasing is expected after administration of study drug, if subject received GnRH agonist for treatment of prostate cancer.
- •Has other chemotherapy planned within 14weeks from administration of study drug, except for androgen deprivation therapy.
- •Has no willing of using method of contraception throughout the study period.
- •Systolic Blood Pressure < 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure < 60mmHg and/or ≥100mmHg at Screening
- •QTcF >450msec at Screening ECG.
- •HbA1c level is high the upper limit of normal of reference range.
- •Serum AST, ALT or Creatinine > 1.5times the upper limit of normal at Screening.
- •Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis.
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject.
研究组 & 干预措施
DWJ108J (leuprolide acetate)
Experimental
DWJ108J (leuprolide acetate)
干预措施: Leuprolide Acetate (Drug)
Leuplin DPS Inj
Active Comparator
Leuplin DPS Inj
干预措施: Leuprolide Acetate (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: Day 99
Area under the plasma concentration versus time curve (AUC)
时间窗: Day 99
AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Pharmacokinetic Study of JNJ-56021927 When Taken Orally as Tablet Formulation in Healthy Male Japanese ParticipantsHealthyNCT02835508Janssen Pharmaceutical K.K.18
Unknown
1 期
Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult VolunteersHealthyNCT04827472Daewoong Pharmaceutical Co. LTD.36
招募中
1 期
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult VolunteersHealthy VolunteersNCT06119945Daewoong Pharmaceutical Co. LTD.44
已完成
1 期
A Study of JNJ-77242113 in Healthy Japanese and Chinese ParticipantsHealthyNCT05062200Janssen Pharmaceutical K.K.36
撤回
1 期
A Study of JNJ-75105186 in Healthy Japanese and Chinese ParticipantsHealthyNCT05159128Janssen Pharmaceutical K.K.