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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacodynamic Interaction; Healthy Subjects

Treatments: Drug: darexaban; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01409603

2009-015762-64 (EudraCT Number)

150-CL-039

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 6 patient groups

Treatment arm A

Experimental group

Description:

darexaban, wash-out, naproxen, wash-out, combination therapy

Treatment:

Drug: Naproxen

Drug: darexaban

Treatment arm B

Experimental group

Description:

darexaban, wash-out, combination therapy, wash-out, naproxen

Treatment:

Drug: Naproxen

Drug: darexaban

Treatment arm C

Experimental group

Description:

naproxen, wash-out, darexaban, wash-out, combination therapy

Treatment:

Drug: Naproxen

Drug: darexaban

Treatment arm D

Experimental group

Description:

naproxen, wash-out, combination therapy, wash-out, darexaban

Treatment:

Drug: Naproxen

Drug: darexaban

Treatment arm E

Experimental group

Description:

combination therapy, wash-out, naproxen, wash-out, darexaban

Treatment:

Drug: Naproxen

Drug: darexaban

Treatment arm F

Experimental group

Description:

combination therapy, wash-out, darexaban, wash-out, naproxen

Treatment:

Drug: Naproxen

Drug: darexaban