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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

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: PCO371 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers
Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: PCO371
Single oral dose of PCO371
Drug: PCO371
Placebo Comparator: Placebo Comparator
Single oral dose of placebo
Drug: Placebo



Primary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: 15days or 22days ]
  2. Safety as assessed by temperature [ Time Frame: 15days or 22days ]
  3. Safety as assessed by systolic blood pressure, diastolic blood pressure [ Time Frame: 15days or 22days ]
  4. Safety as assessed by pulse rate [ Time Frame: 15days or 22days ]
  5. Safety assessed by physical findings examinations, including weight [ Time Frame: 15days or 22days ]
  6. Safety as assessed by Laboratory test values [ Time Frame: 15days or 22days ]
    Laboratory tests include hematology, biochemistry, urine analysis and coagulation

  7. Safety as assessed by ECGs [ Time Frame: 15days or 22days ]
  8. 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 ]
  9. Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371 [ Time Frame: 15days or 22days ]

Secondary Outcome Measures :
  1. 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 ]
  2. The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371 [ Time Frame: 15days ]
  3. The Nephrogenous cAMP of PCO371 [ Time Frame: 15days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475616


Locations
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United States, California
Wcct Global
Cypress, California, United States
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
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Study Director: Ger Rikken Chugai Pharmaceutical
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Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02475616    
Other Study ID Numbers: PCO001US
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015