A Phase 1, Open-Label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for Treatment of Anemia in Patients Receiving Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
研究概览
简要总结
This is a Phase 1, Open-label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for treatment of anemia in patients receiving chemotherapy.
详细描述
A total of up to approximately 24 patients will be enrolled to receive Desidustat in an open-label manner.
The study is divided into three cohorts as given below:
- Cohort I: Single-dose 100 mg
- Cohort II: Single-dose 150 mg
- Cohort III: Single-dose 200 mg
Note:- After evaluation of PK data of 100 mg dose cohort, next cohort with higher dose will be decided. Maximum dose of Desidustat will not be exceeded than 200 mg.
First cohort will be given 100 mg single dose of Desidustat. On completion of safety and PK evaluation of first cohort,the next cohort with escalated single dose (150 mg) of Desidustat will be initiated. Similar way third cohort with 200 mg single dose will be initiated after safety evaluation of 150 mg cohort data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-myeloid malignancy.
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Male and Female patients at least 18 years old at the time of signing the ICF.
- •Anemia caused by cancer treatment (chemotherapy) defined as Hb ≤11.0 g/dL at screening.
- •Subjects with eGFR >60 mL/min/1.73 meter sequre at screening.
- •Weight should be ≥50 kg.
- •Willingness to participate after informed consent.
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- •Ability to swallow and retain oral medication.
排除标准
- •Known hypersensitivity to Desidustat and excipients in the investigational drug product.
- •History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the time of screening.
- •History of RBC transfusion <4 weeks prior enrollment.
- •History or presence of any clinically significant electrocardiogram abnormalities during screening.
- •Cardiovascular risks, such as myocardial infarction, stroke, heart failure or thromboembolic event (e.g., deep vein thrombosis (DVT) or pulmonary embolism) within previous 6 months of screening
- •Major illness and/or major surgery in the last 3 months.
- •Planned elective surgery during the study
- •Receiving or has received any investigational drug within the 30 days before receiving Desidustat.
- •Any participants with poor peripheral venous access.
- •A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
- •Female patients with following criteria will not be recruited:
- •History of pregnancy or lactation in the past 3 months
- •Fertile female volunteers not protected against pregnancy by adequate long-term antifertility measures
- •History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
- •Using hormone replacement therapy
- •Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
- •Positive serum β-hCG level at the screening visit
- •Abnormal baseline laboratory investigations as follows:
- •WBC count ≤ 3 x 103/uL
- •Platelets count ≤ 100 x 103/uL
- •Bilirubin ≥ 1.5 mg/dL
- •ALT and/or AST ≥ 2.5 times of the ULN.
研究组 & 干预措施
Desidustat tablet
干预措施: Desidustat (Drug)
结局指标
主要结局
To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.
时间窗: Change from Baseline to Day 7 and Day 30
The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading
次要结局
- Change of hemoglobin measurement from baseline(Change from baseline to Day 7 and Day 30)