A Single Ascending Dose Study of PCO371 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males. Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.

Official Title
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A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PCO371
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 18 to 45 years. Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2) Able and willing to abide by the protocol Exclusion Criteria: Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCO371<br>Single oral dose of PCO371 | Drug: PCO371<br> <br> |
| Placebo Comparator: Placebo Comparator<br>Single oral dose of placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by adverse events |  | 15days or 22days | 
| Safety as assessed by temperature |  | 15days or 22days | 
| Safety as assessed by systolic blood pressure, diastolic blood pressure |  | 15days or 22days | 
| Safety as assessed by pulse rate |  | 15days or 22days | 
| Safety assessed by physical findings examinations, including weight |  | 15days or 22days | 
| Safety as assessed by Laboratory test values | Laboratory tests include hematology, biochemistry, urine analysis and coagulation | 15days or 22days | 
| Safety as assessed by ECGs |  | 15days or 22days | 
| Plasma concentrations and PK parameters (AUC, Cmax, Tmax, total clearance, volume of distribution and T1/2) of PCO371 in healthy male volunteers |  | 15days or 22days | 
| Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371 |  | 15days or 22days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time profile of serum/plasma concentrations in albumin-corrected total calcium (Ca); 25-hydroxy vitamin D (vit D), 1,25-dihydroxy vit D, and 24,25-dihydroxy vit D; phosphate; magnesium; and cAMP of PCO371 |  | 15days | 
| The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371 |  | 15days | 
| The Nephrogenous cAMP of PCO371 |  | 15days |