CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
St. Johns wortdrug
Likely dose
St. Johns wort 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01311362
NCT01311362N/ACompleted

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

Gerd Mikus·observational·Posted Mar 9, 2011·Updated May 31, 2017

In Brief

An observational study evaluating St. Johns wort for Drug Interactions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.3 years ago

Interventions

St. Johns wortdrug

* 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