A Single Ascending Dose Study of PCO371 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475616
• Other study ID #: PCO001US
• Status: Terminated
• Phase: Phase 1
• First received: June 2, 2015
• Last updated: November 17, 2015
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PCO371

• Placebo

Locations

Country	Name	City	State
United States	Wcct Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by adverse events		15days or 22days	Yes
Primary	Safety as assessed by temperature		15days or 22days	Yes
Primary	Safety as assessed by systolic blood pressure, diastolic blood pressure		15days or 22days	Yes
Primary	Safety as assessed by pulse rate		15days or 22days	Yes
Primary	Safety assessed by physical findings examinations, including weight		15days or 22days	Yes
Primary	Safety as assessed by Laboratory test values	Laboratory tests include hematology, biochemistry, urine analysis and coagulation	15days or 22days	Yes
Primary	Safety as assessed by ECGs		15days or 22days	Yes
Primary	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	No
Primary	Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371		15days or 22days	No
Secondary	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	No
Secondary	The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371		15days	No
Secondary	The Nephrogenous cAMP of PCO371		15days	No