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

NCT02962440 | Completed Phase 1

• 3 other identifiers: NN8640-42372016-000096-24U1111-1178-1251
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

Somapacitan

EXPERIMENTAL

Drug: somapacitan

Interventions

somapacitan DRUG

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

Somapacitan

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34601071 DERIVED

MeSH Terms

Interventions

somapacitan

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

NL (1)