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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43034

Enrollment

Registered

2016-10-19

Start date

2016-10-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pituitary adenoma pituitary tumor

Interventions

A single dose of 1.2 milligrams (mg) radiolabeled BIM23B065 as an injection under the skin (subcutaneous).

[14C]-BIM23B065

mass balance

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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,

Design outcomes

Primary

Measure	Time frame
Mass balance recovery of total radioactivity in urine and faeces. Determination of plasma levels of BIM23B065 and BIM23B133 (main metabolite identified in the nonclinical species), Determination of total radioactivity in blood and plasma.	—

Secondary

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

Measure

Time frame

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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)