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

Completed

Conditions: pituitary adenoma
pituitary tumor
10014713

Registration Number: NL-OMON43034

Lead Sponsor: Ipsen Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

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,

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mass balance recovery of total radioactivity in urine and faeces.<br /><br><br /><br>Determination of plasma levels of BIM23B065 and BIM23B133 (main metabolite<br /><br>identified in the nonclinical species),<br /><br><br /><br>Determination of total radioactivity in blood and plasma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Metabolite profiling and identification in plasma, urine, and faeces, where<br /><br>possible.<br /><br><br /><br>Safety endpoints:<br /><br>* AEs,<br /><br>* Physical examination,<br /><br>* Vital signs including blood pressure and heart rate (in supine and/or<br /><br>standing positions),<br /><br>* Twelve-lead electrocardiogram (ECG) (in supine and/or standing positions),<br /><br>* Local tolerance,<br /><br>* Concomitant administrations (where applicable; no concomitant therapy is<br /><br>allowed at study entry, but any medication prescribed during the study will be<br /><br>recorded),<br /><br><br /><br>Clinical safety laboratory tests (haematology, coagulation, blood biochemistry,<br /><br>urinalysis).</p><br>