Clinical trial NCT02962440: A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
Official title: A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Subcutaneous Dosing in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 7
Sex: MALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
timeFrame: Assessed up to 35 days after trial product administration
measure: Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
timeFrame: Assessed up to 35 days after trial product administration
measure: Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
timeFrame: Assessed up to 35 days after trial product administration
Secondary outcomes:
measure: Total recovery of administered 3H label (sum of urine, faeces and expired air)
timeFrame: Assessed up to 36 days after trial product administration
measure: Blood to plasma ratio of [3H]-somapacitan related material
timeFrame: Assessed up to 36 days after trial product administration
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1.