Most entrepreneurs new to drug development are focused on demonstrating the pharmacology of their compound, and rightfully so. There is no point in spending years and millions of dollars in the development of something that does not have a chance of demonstrating efficacy in a clinical trial. Often, however, too little planning is done to position the investigational compound as an actual drug for the treatment of human disease.
Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.
During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences
Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.
Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, announced today that it has begun its first pediatric clinical trial of VRS-317, the company's proprietary once monthly form of recombinant human growth hormone (rhGH), in children with Growth Hormone Deficiency (GHD). The Versartis Trial In Children to Assess Long-Acting Growth Hormone (VERTICAL) study is being conducted in up to 26 sites in the United States and was initiated following the successful completion of a Phase I study in adults with GHD.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).
ImmusanT announced recently that it has initiated clinical trials in New Zealand, Australia and the U.S. to evaluate Nexvax2, the first therapeutic vaccine for patients with celiac disease.
MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the completion of its Phase 1 clinical trial for MRX-I, its first development-stage antibiotic drug candidate.