Clinical Trial: A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single-center, Randomized, 2-Period, Crossover, Study to Explore The Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of EOS789 in Patients With Chronic Kidney Disease and

  • Safety: Incidences of adverse events [ Time Frame: Up to Day 42 in each treatment sequence ]
    Incidences of adverse events
  • Safety: Change from baseline in vital signs [ Time Frame: Up to Day 42 in each treatment sequence ]
    Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
  • Safety: Change from baseline in clinical laboratory tests [ Time Frame: Up to Day 42 in each treatment sequence ]
    Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
  • Safety: Change from baseline in 12 lead ECGs [ Time Frame: Up to Day 42 in each treatment sequence ]
    Change from baseline in 12 lead ECGs


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Pharmacokinetics: Plasma concentration of EOS789 [ Time Frame: Day 4, 9, 10, 11 in the first treatment sequence in each period ]
    • Pharmacokinetics: Total exposure (area under the curve [AUC]) [ Time Frame: Day 10 in the first treatment sequence in each period ]
    • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Day 10 in the first treatment sequence in each period ]
    • Pharmacokinetics: Time to reach Cmax (Tmax) [ Time Frame: Day 10 in the first treatment sequence in each period ]
    • Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state [ Time Frame: Day 9 in the first treatment sequence in each period ]
    • Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus [ Time Frame: Days 11 to 13 in the first treatment sequence and second treatment sequence in each period ]
    • Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13 [ Time Frame: Day 13 in the first treatment sequence and second treatment sequence in each period ]


    Original Secondary Outcome: Same as current

    Information By: Chugai Pharmaceutical

    Dates:
    Date Received: November 11, 2016
    Date Started: December 2016
    Date Completion: December 2019
    Last Updated: January 30, 2017
    Last Verified: January 2017