A Single Ascending Dose Study of PCO371 in Healthy Volunteers
- Registration Number
- NCT02475616
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCO371 PCO371 Single oral dose of PCO371 Placebo Comparator Placebo Single oral dose of placebo
- Primary Outcome Measures
Name Time Method 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 15days or 22days Laboratory tests include hematology, biochemistry, urine analysis and coagulation
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
Name Time Method The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371 15days The Nephrogenous cAMP of PCO371 15days 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
Trial Locations
- Locations (1)
Wcct Global
🇺🇸Cypress, California, United States