A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: somapacitan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02962440

2016-000096-24 (EudraCT Number)

NN8640-4237

U1111-1178-1251 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.

Enrollment

7 patients

Sex

Male

Ages

45 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male, aged 45-64 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.