A Single Ascending Dose Study of PCO371 in Healthy Volunteers

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: PCO371

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCO371; Single oral dose of PCO371	Drug: PCO371
Placebo Comparator: Placebo Comparator; Single oral dose of placebo	Drug: Placebo

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Investigators: Study Director: Ger Rikken, Chugai Pharmaceutical

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PCO001US