Desidustat in the treatment of chemotherapy induced anemia
- Conditions
- Health Condition 1: D648- Other specified anemias
- Registration Number
- CTRI/2020/11/029033
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Diagnosis of non-myeloid malignancy.
2. Ability to comprehend and willingness to sign a written ICF for the study.
3. Male and Female patients at least 18 years old at the time of signing the ICF.
4. Anemia caused by cancer treatment (chemotherapy) defined as Hb <=11.0 g/dL at screening.
5. Subjects with eGFR >60 mL/min/1.73 m2 at screening.
6. Weight should be >=50 kg.
7. Willingness to participate after informed consent.
8. Females will not be pregnant or lactating, and females of childbearing potential and males will
agree to use contraception.
9. Ability to swallow and retain oral medication.
1. Known hypersensitivity to Desidustat and excipients in the investigational drug product.
2. History or presence of significant alcoholism, smoking or drug of abuse within 30 days at the
time of screening.
3. History of RBC transfusion ï?¼4 weeks prior enrollment.
4. History or presence of any clinically significant electrocardiogram abnormalities during
screening.
5. 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
6. Major illness and/or major surgery in the last 3 months.
7. Planned elective surgery during the study
8. Receiving or has received any investigational drug within the 30 days before receiving
Desidustat.
9. Any participants with poor peripheral venous access.
10.A positive test result for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen
(HBsAg) or hepatitis C virus (HCV) antibody at screening visit.
11. 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
12. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety and tolerability of Desidustat following a single oral dose of 100 or 150 or 200 <br/ ><br>mg in patients with chemotherapy induced anemia.Timepoint: Day 1,Day 7 and Day 30
- Secondary Outcome Measures
Name Time Method To assess the blood and urine pharmacokinetics (PK) of Desidustat and its metabolites in blood <br/ ><br>following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.Timepoint: 1) Blood samples at pre-dose and then 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, <br/ ><br>48.0 and 72.0 hour post the single dose administration.2) Urine PK collection will occur relative to dosing of Desidustat at pre-dose and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance.3)To assess the hemoglobin measurement on Day 7 and Day 30 following a single oral dose of <br/ ><br>100 or 150 or 200 mg in patients with chemotherapy induced anemia.