Status:
COMPLETED
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
Lead Sponsor:
Prothya Biosolutions
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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 sin...
Eligibility Criteria
Inclusion
- Male or female of nonchildbearing potential.
- Healthy subjects.
Exclusion
- 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.
Key Trial Info
Start Date :
November 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05205863
Start Date
November 12 2021
End Date
September 3 2022
Last Update
April 8 2024
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands