TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend Capsule

2014-08-27 03:27:41 | BioPortfolio


The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg formulated in capsules with 2 different formulations and as a tablet in healthy volunteers


This is a Phase I, open-label, 3-way crossover trial in 12 healthy adult volunteers to compare the oral bioavailability of a single 200 mg intake of TMC435350 salt, formulated as 2 different solid formulations (a tablet and a capsule) to that of a single 200 mg intake of TMC435350 salt, formulated as a powder blend in a capsule. TMC435350 is a protease inhibitor in development for treatment of chronic hepatitis C virus (HCV) infection. During 3 sessions, each volunteer will receive 3 treatments according to a classical 6-sequence, 3-period Williams design.The treatments administered are: Treatment A: single dose of 200 mg TMC435350 salt, formulated as a powder blend filled in a capsule. Treatment B: single dose of 200 mg TMC435350 salt, formulated in a tablet. Treatment C: single dose of 200 mg. MC435350 salt, formulated in beads filled in a capsule. All medication intakes will be oral and under fed conditions. There will be a washout period of at least 7 days between medication intakes in subsequent treatment sessions. Full pharmacokinetic profiles of TMC435350 will be determined up to 72 hours after administration in each session. Safety and tolerability will be monitored continuously throughout the trial. Treatments A, B and C: TMC435350 200mg on Day 1 of each session.Intakes will be oral and in fed conditions.

Study Design

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


Hepatitis C






Tibotec Pharmaceuticals, Ireland

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:27:41-0400

Clinical Trials [917 Associated Clinical Trials listed on BioPortfolio]

TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.

The purpose of this study is to assess the interactions seen when somebody doses with TMC435350 and Rifampin (commercial form of antibiotic).

TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers

The purpose of this study is to evaluate the safety and tolerability of three different doses of TMC435350 compared to placebo in healthy Japanese males.

TMC435350-TiDP16-C201 - OPERA 1: A Study of the Hepatitis C Virus (HCV) Protease Inhibitor TMC435350 or Placebo Administered With or Without the Standard of Care in Treatment Naive and Treatment Experienced Patients Infected With Genotype 1 Hepatitis C Vi

The purpose of this study is to evaluate the affectiveness, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin. ...

TMC435350-TiDP16-C202: A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Never Received Treatment for Their Hepatitis C Infection.

The primary objective of this study is to assess the activity of TMC435 on hepatitis C virus genotype 2, 3, 4, 5 and 6 replication when administered for 7 days to patients who have never b...

Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients

Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the...

PubMed Articles [1360 Associated PubMed Articles listed on BioPortfolio]

Low Serum Hepatitis B Surface Antigen Level Predicts Compensated Cirrhosis Caused by Chronic Hepatitis B in HBeAg Positive Patients in East China.

Serum hepatitis B surface antigen (HBsAg) levels are associated with fibrosis in patients with chronic hepatitis B (CHB) infection.

Quantitative hepatitis B surface antigen combined with hepatitis B e antigen as sustained virological response predictors during extended therapy with Peginterferon alfa-2a for hepatitis B e antigen-positive chronic hepatitis B.

The best strategy for chronic hepatitis B patients with poor response to 48 weeks of Peginterferon-based therapy has been controversial and the predictive value of hepatitis B surface antigen (HBsAg),...

Evolution and function of the HCV NS3 protease in patients with acute hepatitis C and HIV coinfection.

Little is known about the importance of the hepatitis C virus (HCV) NS3 protease in acute hepatitis C. In this prospective study, 82 consecutive patients with acute hepatitis C and human immunodeficie...

Hepatitis C Seroprevalence and Risk Factors in Adult Population of Chaharmahal and Bakhtiari Province of Iran in 2013.

Hepatitis C is the second leading viral infectious disease worldwide. In Iran, hepatitis C is the most important and prevalent reason for chronic hepatitis and liver cirrhosis in the multi transfused ...

The Cascade of Care for an Australian Community-Based Hepatitis C Treatment Service.

Hepatitis C treatment uptake in Australia is low. To increase access to hepatitis C virus treatment for people who inject drugs, we developed a community-based, nurse-led service that linked a viral h...

Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

More From BioPortfolio on "TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend Capsule"

Quick Search

Relevant Topics

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Searches Linking to this Trial