check_circleStudy Completed
Hemophilia A; Hemophilia B
Bayer Identifier:
19592
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity
Key Participants Requirements
Sex
MaleAge
18 - 65 YearsTrial summary
Enrollment Goal
6Trial Dates
May 2018 - February 2019Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1093884Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Chaim Sheba Medical Center | Ramat Gan, 5262000, Israel |
Primary Outcome
- AUC (0-tlast) of BAY1093884 in plasmaArea under the concentration vs. time curve from time 0 to the last data point > LLOQdate_rangeTime Frame:Up to 15 days after drug administration
- AUC(0-tlast)/D of BAY1093884 in plasmaAUC(0-tlast) divided by dosedate_rangeTime Frame:Up to 15 days after drug administration
- Cmax of BAY1093884 in plasmaMaximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:Up to 15 days after drug administration
- Cmax/D of BAY1093884 in plasmaCmax divided by dosedate_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 assaydate_rangeTime Frame:Up to 15 days after drug administration
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1