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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCO371 | Experimental | Single oral dose of PCO371 |
|
| Placebo Comparator | Placebo Comparator | Single oral dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCO371 | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ger Rikken | Chugai Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wcct Global | Cypress | California | United States |
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| ID | Term |
|---|---|
| C000628187 | PCO371 |
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|
| 15days |
| The Nephrogenous cAMP of PCO371 | 15days |