Bioavailability & Food Effect of different formulations of Simeprevir
Research type
Research Study
Full title
A Phase 1, open-label, randomized, 2-panel, 3-way crossover study in healthy adult subjects to assess the relative bioavailability of simeprevir following single dose administration of age-appropriate oral formulation candidates, compared to the 150-mg oral capsule, and to assess the effect of food on the bioavailability of simeprevir following single dose administration of a selected age-appropriate oral formulation candidate.
IRAS ID
173137
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Janssen Sciences Ireland UC
Eudract number
2014-005448-17
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
The medicines tested in this study are two new oral dosage forms of a compound called simeprevir. The Sponsor is developing these study drug dosage forms to potentially be used in paediatric patients (children) for the treatment of hepatitis C virus infections, which can lead to liver disease.
Simeprevir 150 mg oral capsules have been approved for the treatment of chronic hepatitis C infection in adult patients. The two new dosage forms of simeprevir being tested in this study are: 50mg capsules with minitablets, and 50mg dispersible tablets. These two new dosage forms will be compared to the approved 150 mg oral capsule.
The main purpose of the study is to see how simeprevir is taken up (absorbed) by the body, after giving a single dose of two different oral dosage forms (capsules with minitablets and dispersible tablets), compared to a single dose oral capsule. A further aim is to look at how this process is possibly altered by food, by giving a single dose of one of the new dosage forms in the presence and absence of meal. The study will also investigate how safe the different dosage forms of the single dose study drug are and how well they are tolerated after dosing. The acceptability of taste of the dosage forms will also be assessed.This study will recruit 48 healthy adults, between the ages of 18 and 55 years, divided over 2 panels of 24 each.
Blood samples for pharmacokinetic analysis will be collected. Vital signs, electrocardiogram measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0039
Date of REC Opinion
9 Apr 2015
REC opinion
Further Information Favourable Opinion