BAY94-9027 PK Study Comparing to Another Long Acting Product

Study Overview
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Brief Summary
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The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Official Title
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Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Damoctocog (Jivi, BAY94-9027)
* Drug: Elocta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, age 18 to 65 years. Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1% ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records Exclusion Criteria: Evidence of current or past inhibitor antibody: History of any congenital or acquired coagulation disorders other than hemophilia A. Platelet count <75,000/mm*3. Abnormal renal function (serum creatinine >2 x the upper limit of the normal range). Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY94-9027 and Elocta<br>Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment | Drug: Damoctocog (Jivi, BAY94-9027)<br>* 60 international units (IU)/kg, given as a 10 minute injection, 1 dose<br>Drug: Elocta<br>* 60 IU/kg, given as a 10 minute injection, 1 dose<br>|
| Experimental: Elocta and BAY94-9027<br>Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment | Drug: Damoctocog (Jivi, BAY94-9027)<br>* 60 international units (IU)/kg, given as a 10 minute injection, 1 dose<br>Drug: Elocta<br>* 60 IU/kg, given as a 10 minute injection, 1 dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC from time 0 to the last data point | Area under the concentration time profile curve. | Pre-Dose and up to 120 hours post dose |