Status:
COMPLETED
Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin
Lead Sponsor:
Gerd Mikus
Conditions:
Drug Interactions
Eligibility:
All Genders
18-65 years
Brief Summary
The aim of the present study is to assess the impact of the OATP1B1 genotype (SLCO1B1\*15 vs. wild type; \~2% SLCO1B1\*15 haplotypes in Caucasian population) and the CYP2C9 genotype (\*2 and \*3 allel...
Eligibility Criteria
Inclusion
- Good state of health (physically and mentally)
- Able to communicate well with the investigator, to understand and comply with the requirements of the study
- Voluntarily signed informed consent after full explanation of the study to the participant.
- No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations ≥ 3 × ULN. Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
- Known genotype for CYP2C9 and OATP1B1 polymorphism.
- Agreement to abstain from alcoholic beverages during the time of the study.
- Females must agree to use a reliable contraception (Pearl Index \<1%), e.g. double barrier method.
Exclusion
- Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
- Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
- Any participation in a clinical trial within the last month before inclusion
- Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
- Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
- Regular smoking
- Blood donation within 6 weeks before first study day
- Excessive alcohol drinking (more than approximately 20 g alcohol per day)
- Inability to communicate well with the investigator due to language problems or poor mental development
- Inability or unwillingness to give written informed consent
- Known or planned pregnancy or breast feeding
- Pre-existing moderate or severe liver impairment
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01425229
Start Date
June 1 2011
End Date
December 1 2012
Last Update
May 31 2017
Active Locations (1)
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1
University Hospital Heidelberg
Heidelberg, Germany