Clinical trial NCT01022125: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Virus
Keywords: TMC435-TiDP16-C121
TMC435-C121
TMC435
TMC435350
Protease inhibitor
HCV
Hepatitis C
Lead sponsor: Tibotec Pharmaceuticals, Ireland
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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.
Secondary outcomes:
measure: Safety and tolerability following administration of single doses of 150 mg TMC435
timeFrame: AEs: continuously: laboratory, vital signs and ECG parameters: 3 visits per treatment, for 4 treatment periods
Other outcomes:
Locations:
Study officials:
affiliation: Tibotec Pharmaceutical Limited
name: Tibotec Pharmaceuticals Clinical Trial
role: STUDY_DIRECTOR
References: