TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

Hepatitis C Virus Clinical Trial

Official title:

A Phase I Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule and to Assess the Effect of Food on the Bioavailability of TMC435 Following Intake of the Phase IIb Capsule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022125
• Other study ID #: CR016744
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2009
• Last updated: May 13, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Tibotec Pharmaceuticals, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Agriculture and Food Development Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the levels of TMC435 in the blood circulation after intake of 2 tablet formulations with the level of TMC435 in the blood circulation after intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood circulation after intake of the capsule formulation fasted or following a meal.

Description:

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), single dose, crossover (volunteers will receive different interventions sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 as a capsule formulation taken fasted (Treatment A) and following a meal (Treatment B). In addition, the study will evaluate the levels of TMC435 in the blood circulation after intake of a single dose of 150 mg TMC435 as 2 different tablet formulations (Treatments C and D). There will be a 14-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all four treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (day of first dosing) and/or Day 4 of each treatment period, and 4 weeks after the last treatment. Each volunteer will receive 4 treatments, about 14 days apart from each other. Each treatment consists of one single dose of 150 mg TMC435.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Non-smoker for at least 3 months

• Body Mass Index of 18.0 to 30.0 kg/m2

• Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

• Infection with Hepatitis A, B or C virus

• Infection with the human immunodeficiency virus (HIV)

• Women who are pregnant or breastfeeding

• History of, or any current medical condition which could impact the safety of the participant in the study

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• TMC435

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec Pharmaceuticals, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and extent of absorption of TMC435 following administration of the tablet vs the capsule formulations and rate and extent of absorption of TMC435 following administration of the capsule formulation fasted or with food		Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (4) are 14 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken.	No
Secondary	Safety and tolerability following administration of single doses of 150 mg TMC435		AEs: continuously: laboratory, vital signs and ECG parameters: 3 visits per treatment, for 4 treatment periods	No