NCT01405989

Brief Summary

The primary objective of this study is to determine the effect of ketoconazole on the blood concentrations of darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with ketoconazole.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
Last Updated

March 5, 2014

Status Verified

July 1, 2011

Enrollment Period

2 months

First QC Date

July 28, 2011

Last Update Submit

March 3, 2014

Conditions

Pharmacokinetics of Darexaban and MetabolitesHealthy Subjects

Keywords

PharmacokineticsdarexabanketoconazolePhase 1

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of darexaban and its metabolites assessed by plasma concentration

    Plasma samples are taken until 72 hours (darexaban alone) or 144 hours (combination of darexaban and ketoconazole) after darexaban dosing

Secondary Outcomes (1)

  • Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events

    16 days

Study Arms (2)

Treatment arm A

EXPERIMENTAL

darexaban, wash-out, ketoconazole + darexaban

Drug: darexabanDrug: ketoconazole

Treatment arm B

EXPERIMENTAL

ketoconazole + darexaban, wash-out, darexaban

Drug: darexabanDrug: ketoconazole

Interventions

darexabanDRUG

oral

Also known as: YM150
Treatment arm ATreatment arm B
ketoconazoleDRUG

oral

Also known as: Nizoral
Treatment arm ATreatment arm B

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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 ketoconazole or any components of the formulation used
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Aster

Paris, 75015, France

Location

MeSH Terms

Interventions

darexabanKetoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic 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

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 5, 2014

Record last verified: 2011-07

Locations

FR(1)