A Phase I, Open-label, Single Dose Study to Evaluate the Disposition, Metabolism, and Excretion of Radiolabelled [14C]-BIM23B065 Following Subcutaneous Administration in Healthy Male Subjects - [14C]-BIM23B065 mass balance study

Ipsen Pharmaceuticals0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Provision of written informed consent prior to any study related procedure,
•Male subjects aged between 18 and 64 years of age inclusive at the time of giving informed consent,
•Body mass index (BMI) between 19 and 30 kg/m²
•Good health as determined by a medical and psychiatric history, physical examination, ECG, blood biochemistry, haematology, urinalysis, and serology,
•Vital signs (after 5 minutes resting in a supine position) that are within the following ranges (measurements may be repeated at screening at the discretion of the principal Investigator):
•(a) Systolic blood pressure: 100 to 145 mm Hg,
•(b) Diastolic blood pressure: 60 to 90 mm Hg,
•(c) Heart rate: 50 to 100 beats/min

•Known hypersensitivity to drugs in general, including comparative drugs to the IMP, or any of the components of the formulation,
•Use of any medication, including any prescription, over-the-counter, herbal remedies or other supplements (vitamins and paracetamol excluded), within 14 days prior to dosing,
•Any acute or chronic/history of systemic disease or organ disease including, but not limited to gastrointestinal tract, hepatic, renal, endocrine, metabolic or cardiovascular disease or psychiatric disorder,

发起方

Ipsen Pharmaceuticals