Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors
Summary
This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Solid Tumors
Intervention
ARQ 197 Capsule, ARQ 197 Tablet, ARQ 197 Capsule D, oral
Location
Premiere Oncology
Santa Monica
California
United States
90404
Status
Not yet recruiting
Source
Daiichi Sankyo Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01149720
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Capsule Opacification
Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.
Capsule Endoscopy
Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.
Capsule Endoscopes
A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.
Joint Capsule
The sac enclosing a joint. It is composed of an outer fibrous articular capsule and an inner SYNOVIAL MEMBRANE.
Dietary Supplements
Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)
Clinical Trials
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients who...
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974
This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.
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...
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.
PubMed Articles
A novel plug-controlled colon-specific pulsatile capsule with tablet of curcumin-loaded SMEDDS.
This study developed and evaluated a colon-specific pulsatile capsule with tablet of self-microemulsifying drug delivery system (SMEDDS). This system is based on an impermeable capsule containing a ra...
Objective: To determine the oral bioavailability of a pregabalin capsule relative to a pregabalin solution. Methods: This was an open-label, randomized, crossover study in 12 healthy volunteers. Pharm...
Purpose This phase I, open-label, randomized, 2-part crossover study assessed the safety, pharmacokinetics and relative bioavailability of single doses of the anticancer MET inhibitor foretinib (forme...
The purpose of this work is to evaluate if the coffee-associated malabsorption of tablet levothyroxine (L: -T4) is reduced by soft gel capsule. We recruited 8 patients with coffee-associated L: -T4 ma...
The aim of this study was to investigate biosynthesis genes and chemical components of the capsule of Avibacterium paragallinarum. The sequence of a 10-kb region containing the capsule biosynthetic lo...
