Outcome Measures: |
Primary: 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 | Secondary: 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 | Other: 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., 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
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