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

NCT01409603 | Completed Phase 1

• 2 other identifiers: 150-CL-0392009-015762-64
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacodynamic Interaction; Healthy Subjects

Keywords

Pharmacodynamics; darexaban; naproxen; YM150; Phase 1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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)

Study Arms (6)

Treatment arm A

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Treatment arm B

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Treatment arm C

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Treatment arm D

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Treatment arm E

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Treatment arm F

EXPERIMENTAL

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

Drug: darexaban; Drug: Naproxen

Interventions

darexaban DRUG

oral

Also known as: YM150

Treatment arm A; Treatment arm B; Treatment arm C; Treatment arm D; Treatment arm E; Treatment arm F

Naproxen DRUG

oral

Also known as: Naprosyne

Treatment arm A; Treatment arm B; Treatment arm C; Treatment arm D; Treatment arm E; Treatment arm F

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

SGS Aster

Paris, 75015, France

Location

MeSH Terms

Interventions

darexaban; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

• Principal Investigator

  SGS Aster, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 4, 2011
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

FR (1)