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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01409603
First received: August 1, 2011
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pharmacodynamic Interaction
Healthy Subjects
Drug: darexaban
Drug: Naproxen
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of pharmacodynamics of naproxen [ Time Frame: Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two ] [ Designated as safety issue: No ]

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

Enrollment: 26
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm A
darexaban, wash-out, naproxen, wash-out, combination therapy
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne
Experimental: Treatment arm B
darexaban, wash-out, combination therapy, wash-out, naproxen
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne
Experimental: Treatment arm C
naproxen, wash-out, darexaban, wash-out, combination therapy
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne
Experimental: Treatment arm D
naproxen, wash-out, combination therapy, wash-out, darexaban
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne
Experimental: Treatment arm E
combination therapy, wash-out, naproxen, wash-out, darexaban
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne
Experimental: Treatment arm F
combination therapy, wash-out, darexaban, wash-out, naproxen
Drug: darexaban
oral
Other Name: YM150
Drug: Naproxen
oral
Other Name: Naprosyne

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409603

Locations
France
SGS Aster
Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Principal Investigator: Principal Investigator SGS Aster, Paris, France
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01409603     History of Changes
Other Study ID Numbers: 150-CL-039, 2009-015762-64
Study First Received: August 1, 2011
Last Updated: April 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Astellas Pharma Inc:
Pharmacodynamics
darexaban
naproxen
YM150
Phase 1

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014