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A Single Ascending Dose Study of PCO371 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475616
Recruitment Status : Terminated
First Posted : June 19, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 19, 2015
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Safety as assessed by adverse events [ Time Frame: 15days or 22days ]
  • Safety as assessed by temperature [ Time Frame: 15days or 22days ]
  • Safety as assessed by systolic blood pressure, diastolic blood pressure [ Time Frame: 15days or 22days ]
  • Safety as assessed by pulse rate [ Time Frame: 15days or 22days ]
  • Safety assessed by physical findings examinations, including weight [ Time Frame: 15days or 22days ]
  • Safety as assessed by Laboratory test values [ Time Frame: 15days or 22days ]
    Laboratory tests include hematology, biochemistry, urine analysis and coagulation
  • Safety as assessed by ECGs [ Time Frame: 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 [ Time Frame: 15days or 22days ]
  • Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371 [ Time Frame: 15days or 22days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • 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 [ Time Frame: 15days ]
  • The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371 [ Time Frame: 15days ]
  • The Nephrogenous cAMP of PCO371 [ Time Frame: 15days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Ascending Dose Study of PCO371 in Healthy Volunteers
Official Title  ICMJE A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PCO371
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: PCO371
    Single oral dose of PCO371
    Intervention: Drug: PCO371
  • Placebo Comparator: Placebo Comparator
    Single oral dose of placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 17, 2015)
64
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2015)
72
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02475616
Other Study ID Numbers  ICMJE PCO001US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chugai Pharmaceutical
Study Sponsor  ICMJE Chugai Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ger Rikken Chugai Pharmaceutical
PRS Account Chugai Pharmaceutical
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP