Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Study Overview
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Brief Summary
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This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis

Official Title
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A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Conditions
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Hyperparathyroidism

Intervention / Treatment
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* Drug: KHK7580


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening intact PTH value ≥ 240 pg/mL at the screening Corrected serum calcium ≥ 8.4 mg/dL at the screening Exclusion Criteria: Patients with primary hyperparathyroidism Patients who received cinacalcet within 2 weeks prior to the screening Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening Patients who received parathyroidectomy and/or parathyroid intervention Patients with uncontrolled hypertension and/or diabetes Patients with severe heart disorder Patients with severe hepatic disease Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening Patients who have been judged ineligible to participate in the study by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK7580<br> | Drug: KHK7580<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination | The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination | For 19 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiles of pharmacokinetics | Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed. | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period | 
| Profiles of pharmacodynamics | intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin | For 4-15 days after every dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients, receiving, hemodialysis, Secondary