Clinical Trial: A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commer

Brief Summary: The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.

Detailed Summary:
Sponsor: Albireo

Current Primary Outcome:

• Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following A Single Oral 10 mg A4250 Dose - Tmax [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours ]
• Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - Cmax [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours ]
• Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - AUC 0-t [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours ]
• Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 4 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
• Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 24 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
• Mean (SD) Change in C4 from Day 1 Pre-Dose to 4 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
• Mean (SD) Change in C4 from Day 1 Pre-Dose to 24 h Post-Dose [ Time&n
  
  

  Original Primary Outcome:

  • Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following A Single Oral 10 mg A4250 Dose - Tmax [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h ]
  • Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - Cmax [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8, h, 12 h and 24 h ]
  • Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - AUC 0-t [ Time Frame: Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8, h, 12 h and 24 h ]
  • Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 4 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
  • Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 24 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
  • Mean (SD) Change in C4 from Day 1 Pre-Dose to 4 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose). ]
  • Mean (SD) Change in C4 from Day 1 Pre-Dose to 24 h Post-Dose [ Time Frame: Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-u
    
    

    Current Secondary Outcome:
    
    

    Original Secondary Outcome:
    
    Information By: Albireo
    

    Dates:
    Date Received: November 1, 2016
    Date Started: July 2013
    Date Completion:
    Last Updated: November 15, 2016
    Last Verified: November 2016