Primary :To evaluate the prothrombin time (PT) in healthy volunteers treated with edoxaban alone or preceded by apixaban.Secondary : To assess the effect of edoxaban alone or preceded by apixaban on additional pharmacodynamic (PD) assays: activated…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamics, Pharmacokinetics, Safety
Secondary outcome
n/a
Background summary
Edoxaban is a new investigational compound that may eventually be used for the
treatment of thrombosis, unwanted blood clotting, after major orthopedic
surgery (artificial hip replacement and knee replacement) and in patients with
atrial fibrillation, a heart arrhythmia. Edoxaban is an oral Factor 10 (FXa)
inhibitor that works by blocking a part of the series of steps leading to the
clotting of your blood (in this case activated FXa), Edoxaban is not registered
as a drug in Europe (but is marketed in Japan since April 2011), and has been
given to humans before.
During this study you will also receive Apixaban (marketed as Eliquis), a
registered drug with a similar mechanism of action as the study drug.
Study objective
Primary :
To evaluate the prothrombin time (PT) in healthy volunteers treated with
edoxaban alone or preceded by apixaban.
Secondary :
To assess the effect of edoxaban alone or preceded by apixaban on additional
pharmacodynamic (PD) assays: activated partial thromboplastin time (aPTT),
anti-factor Xa (FXa) activity, thrombin generation assay (TGA) parameters
(endogenous thrombin potential [ETP].
To evaluate the single- and multiple-dose pharmacokinetics of edoxaban and
metabolites.
To evaluate the single-dose pharmacokinetics of apixaban.
To evaluate the safety and tolerability of all treatments.
Study design
Open-label, 2-treatment, 2-way crossover study. Subjects will be randomized to
a treatment sequence in Period 1. Each subject will receive the 2 treatments
listed below in a random order:
* Treatment A: single oral doses of 60 mg edoxaban (administered as 2 x 30 mg)
on Days 1 to 4
* Treatment B: 5 mg apixaban twice daily (bid) (administered as 2 x 2.5 mg)
every 12 hours (q12h) on Days 1 to 3 followed by a single morning dose of
edoxaban 60 mg (administered as 2 x 30 mg) on the morning of Day 4
Intervention
Treatment A: single oral doses of 60 mg edoxaban (administered as 2 x 30 mg) on
Days 1 to 4 (all days inclusive)
Treatment B: 5 mg apixaban twice daily (bid) (administered as 2 x2.5 mg) every
12 hours (q12h) on Days 1 to 3 (all days inclusive) followed by a single
morning dose of edoxaban 60 mg (administered as 2 x 30 mg) on the morning of
Day 4
Study burden and risks
Procedures: pain, light bleeding, heamatoma, possibly an infection.
Chiltern Place Chalfont Park
Gerrards Cross, Buckinghamshire SL9 0BG
GB
Chiltern Place Chalfont Park
Gerrards Cross, Buckinghamshire SL9 0BG
GB
Listed location countries
Age
Inclusion criteria
Healthy male and female (negative pregnancy test)
Age: 18-45 years (inclusive)
BMI: 18.0 - 30.0 (inclusive)
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters blood (males) or 1,0 liters blood (female) in the 10 months preceding the start of the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003375-18-NL |
| CCMO | NL41870.056.12 |