Clinical Trial: Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly

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

Official Title: A Phase IIa, Open-label, Single-arm, Two Stage, Multi-centre Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Repeated Subcutaneous Administration of BIM23B065 i

Brief Summary: The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: The proportion of subjects with growth hormone (GH) ≤2.5µg/l or >50% reduction from mean baseline GH after 6-day titration plus 8-day treatment with BIM23B065 measured by mean serum concentration of GH over 6-hours. [ Time Frame: Day 14 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in blood pressure [ Time Frame: Day -1, day 1, day 3, day 5, day 7, day 10, day 14, day 28 ]
  • Change from baseline in heart rate [ Time Frame: Day -1, day 1, day 3, day 5, day 7, day 10, day 14, day 28 ]
  • Number of cases with orthostatic hypotension [ Time Frame: Day -1, day 1, day 3, day 5, day 7, day 10 and day 14 ]
  • 12 lead ECG parameter: RR interval [ Time Frame: Screening (day-21 to -7), Day -1, day 1, day 3, day 5, day 7, day 10 and day 14, day 28 ]
  • 12 lead ECG parameter: PR/PQ interval [ Time Frame: Screening (day-21 to -7), Day -1, day 1, day 3, day 5, day 7, day 10 and day 14, day 28 ]
  • 12 lead ECG parameter: QRS interval [ Time Frame: Screening (day-21 to -7), Day -1, day 1, day 3, day 5, day 7, day 10 and day 14, day 28 ]
  • 12 lead ECG parameter: QT interval [ Time Frame: Screening (day-21 to -7), Day -1, day 1, day 3, day 5, day 7, day 10 and day 14, day 28 ]
  • 12 lead ECG parameter: QTc interval (calculated according to the Fridericia method) [ Time Frame: Screening (day-21 to -7), Day -1, day 1, day 3, day 5, day 7, day 10 and day 14, day 28 ]
  • Change from baseline in 3 lead holter Electrocardiogram (ECG) [ Time Frame: Day -1, day 1, day 7, day 10 ]
  • The proportion of subjects with <1.0µg/l after 6-day titration plus 8-day treatment with BIM23B065 measured by mean serum concentration of GH over 6-hours. [ Time Frame: Day 14 ]
  • Pharmacokinetic (PK) profile of BIM23B065: Cmax (Observed maximal (peak) concentration) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: tmax (Empirical time of Cmax) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: AUCt (Area under the plasma concentration time curve within a dosage interval (0 to last measurable concentration) after the first dose). [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: AUCτ (Area under the plasma concentration time curve within a dosage interval (0 to 24 hours) after the first dose). [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: AUCinf (Area under the plasma concentration time curve extrapolated to infinity) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: AUC%ext (Percentage of AUC extrapolated) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: t½: (Terminal elimination half-life) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: λz (Elimination rate constant) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: CL/F (Apparent total clearance of the drug from plasma after s.c. administration) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B065: Vz/F (Apparent volume of distribution during terminal phase after s.c. administration) [ Time Frame: Day 7 and 14 ]
  • Change in mean concentration of GH [ Time Frame: Screening (day -21 to -7), day -1, day 7, day 14 ]
  • Change in mean concentration of insulin-like growth factor-1 (IGF-1) [ Time Frame: Screening (day -21 to -7), day -1, day 14, day 28 ±2 ]
  • Change in mean concentration of prolactin (PRL) [ Time Frame: Screening (day -21 to -7), day -1, day 7, day 14 ]
  • IGF-1 reduction to <Upper Limit of Normal (ULN) (age normalised) after 6-day titration and 8-day treatment period [ Time Frame: Day 14 and 28 ]
  • PK profile of BIM23B133: Cmax [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: tmax (Empirical time of Cmax). [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: AUCt (Area under the plasma concentration time curve within a dosage interval (0 to last measurable concentration) after the first dose). [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: AUCτ (Area under the plasma concentration time curve within a dosage interval (0 to 24 hours) after the first dose). [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: AUCinf (Area under the plasma concentration time curve extrapolated to infinity) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: AUC%ext (Percentage of AUC extrapolated) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: t½ (Terminal elimination half-life) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: λz: (Elimination rate constant) [ Time Frame: Day 7 and 14 ]
  • PK profile of BIM23B133: CL/F (Apparent total clearance of the drug from plasma after s.c. administration) [ Time 

    Original Secondary Outcome: Same as current

    Information By: Ipsen

    Dates:
    Date Received: November 10, 2016
    Date Started: January 26, 2017
    Date Completion: June 2017
    Last Updated: February 3, 2017
    Last Verified: February 2017