Healthy Volunteers
Conditions
Brief summary
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days
Interventions
BIOLOGICALCofact
Human prothrombin complex concentrate
Sponsors
PRA Health Sciences
Prothya Biosolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female of nonchildbearing potential. * Healthy subjects.
Exclusion criteria
* Evidence of coagulation disturbances, or disposition for thrombo-embolic events * Liver function tests more than 1.2 times the upper normal limits * Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening. * Prior history of thromboembolic complications including those in first degree relatives. * Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation. * Anaphylactic or systemic reactions to human plasma, plasma products, or blood products. * History of hypersensitivity to active or inactive excipients of VKA * Gastrointestinal disease that may impair VKA absorption.. * Participation in another clinical study \<30 days prior to study entry. * Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator. * Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -1. * Positive pregnancy test at screening, Day -11, or Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak thrombin generation at 30 minutes after end of the Cofact infusion | 30 minutes post Cofact infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ETP | 24 hours post Cofact infusion | Change in endogenous thrombin potential (ETP) over 24 hours after the EOI |
| Concentration in clotting factors | up to Day 15 | Changes in aPTT, PT, and INR |
| Coagulation markers | up to Day 15 | Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S |
| Coagulation activation markers | up to Day 15 | Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs) |
| Safety outcome | up to Day 15 | Frequency and severity of adverse events (AEs) |
Countries
Netherlands
Outcome results
None listed