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Completed

NCT Number: NCT02962440

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

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.

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Key information

Conditions

Age range

45 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somapacitan

Drug

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

Primary outcomes

  1. Total amount of [3H]-somapacitan related material excreted in urine (% of dose)

    Time frame: Assessed up to 35 days after trial product administration

  2. Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)

    Time frame: Assessed up to 35 days after trial product administration

  3. Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)

    Time frame: Assessed up to 35 days after trial product administration

Secondary outcomes

  1. Total recovery of administered 3H label (sum of urine, faeces and expired air)

    Time frame: Assessed up to 36 days after trial product administration

  2. Blood to plasma ratio of [3H]-somapacitan related material

    Time frame: Assessed up to 36 days after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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