At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years inclusive
- ✓BMI 18–35 kg/m² inclusive
- ✓Males or non-pregnant, non-lactating females
- ✓Females of childbearing potential must use adequate non-hormonal contraception (diaphragm with spermicide, intrauterine device) plus condoms; avoid hormonal contraceptives with drospirenone
- ✕Any significant acute or chronic medical illness
- ✕Evidence of organ dysfunction or clinically significant abnormality on physical exam, vital signs, ECG, or lab tests
- ✕Positive hepatitis B and/or C antibody screening
- ✕Positive HIV-1 and/or HIV-2 antibody screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Evaluation of the Pharmacokinetics and Safety of Boceprevir and Ucalm (St John&Apos;s Wort) When Co-administered to Male and Female Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating Boceprevir and St John's Wort for Hepatitis C. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir) together with a herbal remedy commonly used for the treatment of depression (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is taken on its own. Treatment of hepatitis C genotype-1, has recently been significantly improved with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression) for which treated patients may self-medicate with preparations containing St. Johns Wort (SJW). SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW. The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.
Study Details
Timeline
Interventions
Boceprevir as Victrelis(r) 200mg capsules
Each Ucalm(r) tablet contains 300mg of St Johns Wort extract