To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects

Healthy Subjects Clinical Trial

Official title:

A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409603
• Other study ID #: 150-CL-039
• Secondary ID: 2009-015762-64
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2011
• Last updated: April 9, 2013
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: April 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate whether naproxen and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 18.5-30.0 kg/m2

• Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

• Known or suspected hypersensitivity to darexaban or naproxen or any components of the formulation used

• A contra-indication for the use of naproxen

• Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures

• Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.

• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests

• Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)

• Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit

• Donation of blood or blood products within 3 months prior to admission to the Clinical Unit

• Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study

• Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects
• Pharmacodynamic Interaction

Intervention

Drug:
• darexaban
oral
• Naproxen
oral

Locations

Country	Name	City	State
France	SGS Aster	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacodynamics of naproxen		Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two	No
Secondary	Assessment of pharmacodynamics of darexaban		Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two	No
Secondary	Pharmacokinetics of darexaban assessed by plasma concentration		Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen	No
Secondary	Pharmacokinetics of naproxen assessed by plasma concentration		Plasma samples are taken until 12 hours after four days of dosing of naproxen, or the combination with darexaban	No
Secondary	Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events		6 days (for treatment periods with darexaban) or 4 days. (naproxen alone)	Yes

External Links

•   Link to Results on JAPIC