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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desidustat tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desidustat | Drug | A total of 24 participants will be enrolled. The study is divided into three cohorts as given below:
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. | The Common Terminology Criteria for Adverse Event (CTCAE) (Version 4.03 or higher) system will be used for reporting and grading | Change from Baseline to Day 7 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of hemoglobin measurement from baseline | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. | Change from baseline to Day 7 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. |
Inclusion Criteria:
Exclusion Criteria:
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:
Abnormal baseline laboratory investigations as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Deven Parmar, MD | Cadila Healthcare Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCG Manavata Cancer Centre, | Nashik | Mahar Ashtra | 422002 | India |
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| ID | Term |
|---|---|
| C000623340 | desidustat |
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| Change from Baseline to 72 hours in blood |
| Time to reach maximum plasma concentration (Tmax) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Area under the curve from the time of dosing to the last measurable concentration (AUC0-t) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Terminal half life (t1/2) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Elimination rate constant (λz) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Clearance (CL) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Volume of distribution (Vd) | a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. To compute pharmacokinetics, blood PK samples will be collected at pre-dose (<-0.5 h) 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, 48.0 and 72.0 hour post the single dose administration. Patients will be discharged on Day 1 and provide Day 2 and Day 3 PK as an outpatient visit for PK draws. | Change from Baseline to 72 hours in blood |
| Amount recovered in Urine | Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required. | Change from baseline to 24 hours in urine |
| Percent recovered in urine | Urine PK collection will occur relative to dosing of Desidustat at pre-dose (within 2 hours before dosing) and then at the proposed time points (0-6, 6-12 and 12-24 hr) for clearance. Desidustat and the drug metabolite in urine and additional assay may be required. | Change from baseline to 24 hours in urine |