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Trial record 1 of 4 for:    desidustat
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Desidustat in the Treatment of Chemotherapy Induced Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04667533
Recruitment Status : Completed
First Posted : December 14, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Cadila Healthcare Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Chemotherapy Effect Drug: Desidustat Phase 1

Detailed Description:

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:

  1. Cohort I: Single-dose 100 mg
  2. Cohort II: Single-dose 150 mg
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 11, 2020
Actual Primary Completion Date : March 27, 2022
Actual Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Desidustat tablet Drug: Desidustat

A total of 24 participants will be enrolled.

The study is divided into three cohorts as given below:

  1. Cohort I: Single-dose 100 mg
  2. Cohort II: Single-dose 150 mg
  3. Cohort III: Single-dose 200 mg




Primary Outcome Measures :
  1. To evaluate Adverse event of Desidustat following a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia. [ Time Frame: 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


Secondary Outcome Measures :
  1. Change of hemoglobin measurement from baseline [ Time Frame: Change from baseline to Day 7 and Day 30 ]
    a single oral dose of 100 or 150 or 200 mg in patients with chemotherapy induced anemia.


Other Outcome Measures:
  1. Maximum plasma concentration (Cmax) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  2. Time to reach maximum plasma concentration (Tmax) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  3. Area under the curve from the time of dosing to the last measurable concentration (AUC0-t) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  4. Terminal half life (t1/2) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  5. Elimination rate constant (λz) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  6. Clearance (CL) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  7. Volume of distribution (Vd) [ Time Frame: Change from Baseline to 72 hours in blood ]

    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.


  8. Amount recovered in Urine [ Time Frame: Change from baseline to 24 hours 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.

  9. Percent recovered in urine [ Time Frame: Change from baseline to 24 hours 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 meter sequre 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.

Exclusion Criteria:

  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 <4 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667533


Locations
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India
HCG Manavata Cancer Centre,
Nashik, Mahar Ashtra, India, 422002
Sponsors and Collaborators
Cadila Healthcare Limited
Investigators
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Study Chair: Dr Deven Parmar, MD Cadila Healthcare Ltd.
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Responsible Party: Cadila Healthcare Limited
ClinicalTrials.gov Identifier: NCT04667533    
Other Study ID Numbers: DESI.20.001
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cadila Healthcare Limited:
Chemotherapy induced Anemia
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency