Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.

Official Title
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Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease

Conditions
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Anemia of Chronic Kidney Disease

Intervention / Treatment
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* Drug: JTZ-951
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit Hemoglobin value as defined in the protocol Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol Exclusion Criteria: Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol Anemia due to known causes other than chronic kidney disease Known history of hyporesponsiveness to ESAs Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTZ-951 or Placebo<br>Tablets, 1 dose per day for 15 days | Drug: JTZ-951<br>* Subjects will receive JTZ-951 or Placebo<br>Drug: Placebo<br> <br> |
| Experimental: Dose 2 JTZ-951 or Placebo<br>Tablets, 1 dose per day for 15 days | Drug: JTZ-951<br>* Subjects will receive JTZ-951 or Placebo<br>Drug: Placebo<br> <br> |
| Experimental: Dose 3 JTZ-951 or Placebo<br>Tablets, 1 dose per day for 15 days | Drug: JTZ-951<br>* Subjects will receive JTZ-951 or Placebo<br>Drug: Placebo<br> <br> |
| Experimental: Dose 4 JTZ-951 or Placebo<br>Tablets, 1 dose per day for 15 days | Drug: JTZ-951<br>* Subjects will receive JTZ-951 or Placebo<br>Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 15 days | 
| Vital signs and 12 lead ECGs |  | 15 days | 
| Cmax (maximum concentration) |  | 15 days | 
| tmax (time to reach maximum concentration) |  | 15 days | 
| t1/2 (elimination half-life) |  | 15 days | 
| AUC (area under the concentration-time curve) |  | 15 days | 
| AR (accumulation ratio) |  | 15 days | 
| RBC (red blood cell) count |  | 15 days | 
| Hgb (hemoglobin) |  | 15 days | 
| TSAT (transferrin saturation) |  | 15 days | 
| serum ferritin |  | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, chronic kidney disease, hemodialysis