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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: somapacitan

• Registration Number: NCT02962440
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Somapacitan	somapacitan	-

Primary Outcome Measures

Name	Time	Method
Total amount of [3H]-somapacitan related material excreted in urine (% of dose)	Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)	Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)	Assessed up to 35 days after trial product administration

Secondary Outcome Measures

Name	Time	Method
Total recovery of administered 3H label (sum of urine, faeces and expired air)	Assessed up to 36 days after trial product administration
Blood to plasma ratio of [3H]-somapacitan related material	Assessed up to 36 days after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Groningen, Netherlands