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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 20, 2015
November 1, 2015
4 months
June 2, 2015
November 17, 2015
Conditions
Outcome Measures
Primary Outcomes (9)
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 Outcomes (3)
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
Study Arms (2)
PCO371
EXPERIMENTALSingle oral dose of PCO371
Placebo Comparator
PLACEBO COMPARATORSingle oral dose of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wcct Global
Cypress, California, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Ger Rikken
Chugai Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 19, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 20, 2015
Record last verified: 2015-11