check_circleStudy Completed

Hemophilia A; Hemophilia B

A study to assess pharmacokinetics and pharmacodynamics following administration of BAY1093884 in patients with severe hemophilia

Trial purpose

The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia.
The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

Trial summary

Enrollment Goal
6
Trial Dates
May 2018 - February 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1093884
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel

Primary Outcome

  • AUC (0-tlast) of BAY1093884 in plasma
    Area under the concentration vs. time curve from time 0 to the last data point > LLOQ
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • AUC(0-tlast)/D of BAY1093884 in plasma
    AUC(0-tlast) divided by dose
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • Cmax of BAY1093884 in plasma
    Maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Up to 15 days after drug administration
  • Cmax/D of BAY1093884 in plasma
    Cmax divided by dose
    date_rangeTime Frame:
    Up to 15 days after drug administration

Secondary Outcome

  • Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay
    date_rangeTime Frame:
    Up to 15 days after drug administration

Trial design

A Phase 1 Study to assess pharmacokinetics and pharmacodynamics following administration of BAY1093884 in patients with severe hemophilia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1