To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01406002
First received: July 28, 2011
Last updated: April 9, 2013
Last verified: March 2013
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Purpose
The primary objective of this study is to determine the effect of rifampicin on the way the body handles 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 rifampicin.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics of Darexaban and Metabolites Healthy Subjects |
Drug: darexaban Drug: Rifampicin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | An Open-label, One-sequence Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Pharmacokinetics of YM150 (Darexaban) and Metabolites in Young Healthy Male Subjects |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Pharmacokinetics of darexaban and its metabolites assessed by plasma concentration [ Time Frame: Plasma samples are taken until 72 hours after darexaban dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 26 |
| Study Start Date: | January 2010 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment arm 1
darexaban, wash-out, rifampicin + darexaban
|
Drug: darexaban
oral
Other Name: YM150
Drug: Rifampicin
oral
Other Name: Rifadin
|
Detailed Description:
This is an open-label, 1-sequence study in young healthy male subjects to evaluate the effect of multiple daily doses of rifampicin on the PK of darexaban and metabolites after a single dose of darexaban. In addition, safety and tolerability of darexaban administered alone and in combination with rifampicin is evaluated. Eligible subjects are admitted to the clinical unit in the morning of Day -1.
Subjects receive a single dose of darexaban on Day 1. Subjects then receive rifampicin once daily (qd) on Days 4-14.On Day 11, the second single dose of darexaban is given in combination with rifampicin.
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 rifampicin or any components of the formulation used
- Any of the liver function tests (i.e. ALT and AST) 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 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
- 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 Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406002
Locations
| France | |
| SGS Aster | |
| Paris, France, 75015 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Clinical Study Manager | Astellas Pharma Europe BV |
| Principal Investigator: | Prinicpal Investigator | SGS Aster, Paris, France |
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01406002 History of Changes |
| Other Study ID Numbers: | 150-CL-045, 2009-015763-13 |
| Study First Received: | July 28, 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:
|
Pharmacokinetics darexaban YM150 rifampicin Phase 1 |
Additional relevant MeSH terms:
|
Rifampin Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013