Current partner codePEPTIDESDE
NCT02962440·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

7

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

somapacitan

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

Timeline

From registration to results.

  1. First posted

    Nov 11, 2016

  2. Study start

    Nov 2016

  3. Primary completion

    Jan 2017

  4. Study completion

    Jan 2017

  5. Results posted

    Not reported

  6. Registry updated

    Jun 7, 2017

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
45 Years
Maximum age
64 Years
Sex
MALE
Healthy volunteers
Yes

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

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

Novo Nordisk Investigational Site

Groningen, Netherlands

Related trials

More studies on Somapacitan.

Related PeptideStat pages

Put the record in context.

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