Date: 2013-08-21
Type of information:
phase: PK
Announcement: initiation of the study
Company: Arno Therapeutics (USA)
Product: onapristone
Action mechanism: Onapristone is an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor, which is believed to be the mechanism that may inhibit the growth of breast, endometrial and other tumors.
Disease:
Therapeutic area: Cancer - Oncology
Country: France
Trial
details: The PK study is designed to recruit twelve healthy volunteers. It will investigate the pharmacokinetic parameters and examine the effect of food on the absorption of onapristone. All volunteers will receive 10 mg of onapristone, receiving the drug after fasting or with food.
Latest
news: * On August 21, 2013, Arno Therapeutics, a US clinical stage biopharmaceutical company focused on the development of oncology therapeutics, has announced it has initiated a pharmacokinetic (PK) study of onapristone. The initiation follows the submission and approval of an Investigational Medicinal Product Dossier (IMPD) by the French Health Authority, L\'Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM).
The Company has selected Biotrial, a drug evaluation and pharmacology research company, as its contract research organization (CRO) for this trial. The PK study will be conducted by Biotrial\'s clinical unit in Paris, France.
