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Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan

NCT01311362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2017-05-31

Study results available
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Summary

The aim of the present study is to assess the impact of CYP3A4-induction by SJW on steady state ambrisentan and the impact of the cytochrome P450 2C19 (CYP2C19) genotype (\*2 and \*3 allele vs. wild type; \~2-5% poor metabolisers in Caucasian population) on the pharmacokinetics of ambrisentan in healthy volunteers.

Conditions

  • Drug Interactions

Interventions

DRUG

St. Johns wort

* Administration of ambrisentan: 5 mg p.o. q.d. on day 1 and days 3-20 * Administration of SJW: 300 mg p.o. three times a day (t.i.d.) on days 11-20

Sponsors & Collaborators

  • Gerd Mikus

    lead OTHER

Principal Investigators

  • Gerd Mikus, Prof. Dr. · deputy head of department

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311362 on ClinicalTrials.gov