Date: 2014-04-15
Type of information:
phase: 1
Announcement: initiation of the trial
Company: Critical Pharmaceuticals (UK) Nottingham University Hospitals NHS Trust (UK)
Product: nano-enabled intranasal teriparatide
Action mechanism:
Disease: osteoporosis
Therapeutic area: Bone diseases
Country: UK
Trial
details: The clinical trial is a five-way cross-over study design in healthy post-menopausal women representative of the target patient population. The objectives of the study are to understand the levels of the drug in the body (pharmacokinetics) after intranasal administration of three doses of the teriparatide product versus subcutaneous injection of marketed product. The study will also test the performance of two different nasal delivery devices and use scintigraphic imaging to better understand how deposition can influence the levels of drug in the body over time. (NCT01913834)
Latest
news: * On April 15, 2014, Critical Pharmaceuticals, The University of Nottingham and Nottingham University Hospitals NHS Trust have announced the start of the first Phase I clinical trial in healthy post-menopausal women of a nano-enabled intranasal teriparatide product for the treatment of osteoporosis. Teriparatide is a highly-effective treatment for osteoporosis, but it currently needs to be injected every day. The project is using Critical Pharmaceuticals CriticalSorb™ technology to develop a nano-enabled nasal spray formulation of teriparatide that is easy for patients to take and improves efficacy providing optimal drug levels in the body. The project is co-funded by the UK’s innovation agency, the Technology Strategy Board, Critical Pharmaceuticals and the Engineering and Physical Sciences Research Council (EPSRC) as part of their investment in nanoscale technology-enabled solutions in healthcare.
