CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
St. Johns Wortdrug
Likely dose
St. Johns Wort 125 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/NCT01258504
NCT01258504N/ACompleted
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Influence of Cytochrome P450 3A4 (CYP3A4)-Induction by St. John's Wort (SJW) on the Steady State Pharmacokinetics of Bosentan

Gerd Mikus·observational·Posted Dec 13, 2010·Updated May 31, 2017

In Brief

An observational study evaluating St. Johns Wort for Drug Interactions. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9) genotype (\*2 and \*3 allele versus wild type; \~3-5% poor metabolisers in Caucasian population) on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort (SJW) on steady state bosentan which is a CYP3A4 inducer itself.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2010
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.6 years ago

Interventions

St. Johns Wortdrug

* Administration of bosentan: 1 x 125 mg p.o. on days 1 and 20, 2 x 62.5 mg p.o. on day 2, 2 x 125 mg p.o. on days 3-19. * Administration of SJW: 3 x 300 mg daily p.o. on days 11-19 and 2 x 300 mg on day 20