Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT02531568
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to provide written informed consent to participate in this study
* Healthy, free from clinically significant illness or disease
* White Caucasian male or female, aged 18 to 55 years
* Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)
* Must have coagulation test results (including international normalised ratio \[INR\] and activated partial thromboplastin time \[aPTT\]) within the laboratory reference range at Screening.
Exclusion Criteria:
* Presence or history of serious adverse reaction or allergy to any medicinal product
* Known contraindication or adverse reaction to warfarin.
* Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.
* Known contraindications to heparin administration.
* Known contraindication to parenteral vitamin K administration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02531568
Study Brief:
Protocol Section:
NCT02531568