DRUG
somapacitan
All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing \[3H\]-somapacitan
Status
Completed
Phase
Phase 1
Enrollment
7
Locations
1
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing \[3H\]-somapacitan
Timeline
First posted
Nov 11, 2016
Study start
Nov 2016
Primary completion
Jan 2017
Study completion
Jan 2017
Results posted
Not reported
Registry updated
Jun 7, 2017
Outcomes
Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
Time frame · Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
Time frame · Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
Time frame · Assessed up to 35 days after trial product administration
Total recovery of administered 3H label (sum of urine, faeces and expired air)
Time frame · Assessed up to 36 days after trial product administration
Blood to plasma ratio of [3H]-somapacitan related material
Time frame · Assessed up to 36 days after trial product administration
Eligibility
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.
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Groningen, Netherlands
Related trials
Novo Nordisk · SGA · Turner Syndrome
Phase 3
Active, not recruiting
47
2026-07
Novo Nordisk · SGA, Turner Syndrome, Noonan Syndrome, ISS
Phase 3
Active, not recruiting
412
2026-06
Novo Nordisk · Adult Growth Hormone Deficiency
Not applicable
Enrolling by invitation
400
2026-06
Novo Nordisk · Short Stature Children Born Small for Gestational Age (SGA)
Phase 2
Active, not recruiting
62
2026-06
Novo Nordisk · Growth Hormone Deficiency in Children
Phase 3
Completed
200
2026-05
Novo Nordisk · Growth Hormone Deficiency in Children
Not applicable
Enrolling by invitation
200
2026-04
Mayo Clinic · Gastroparesis
Early Phase 1
Recruiting
10
2026-04
Novo Nordisk · Adult Growth Hormone Deficiency
Not applicable
Active, not recruiting
200
2026-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.