Clinical Trial: An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects

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

Official Title: An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects

Brief Summary: The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.

Detailed Summary:
Sponsor: Albireo

Current Primary Outcome:

  • To assess mass balance recovery of total radioactivity in urine [ Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected)) ]
    Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
  • To assess mass balance recovery of total radioactivity in faeces [ Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected)) ]
    Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
  • Metabolite profiling of A4250 of plasma using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate [ Time Frame: Between pre-dose and up to 48 hours post dose ]
    Identification of the chemical structure of each metabolite accounting for greater than 10% of circulating radioactivity in plasma
  • Metabolite profiling of A4250 of urine using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate [ Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected)) ]
    Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Albireo

    Dates:
    Date Received: February 27, 2017
    Date Started: January 31, 2017
    Date Completion:
    Last Updated: March 13, 2017
    Last Verified: March 2017