NCT01311362

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Gerd Mikus · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2011-03-09
• Last updated: 2017-05-31
• Results posted: 2015-06-02

Locations

1 site across 1 country: Germany