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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962440
• Other study ID #: NN8640-4237
• Secondary ID: 2016-000096-24U1
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2016
• Last updated: June 6, 2017
• Start date: November 2016
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 64 Years

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• somapacitan
All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of [3H]-somapacitan related material excreted in urine (% of dose)		Assessed up to 35 days after trial product administration
Primary	Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)		Assessed up to 35 days after trial product administration
Primary	Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)		Assessed up to 35 days after trial product administration
Secondary	Total recovery of administered 3H label (sum of urine, faeces and expired air)		Assessed up to 36 days after trial product administration
Secondary	Blood to plasma ratio of [3H]-somapacitan related material		Assessed up to 36 days after trial product administration