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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02962440 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4237Other id2016-000096-24Other idU1111-1178-1251Other id2016

Overview

Status
Completed
Phase
Phase 1
Enrollment
7 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Netherlands

Start
Nov 2016
Primary completion
Jan 2017
Completion
Jan 2017
First posted
11 Nov 2016 (estimated)
Last update posted
7 Jun 2017
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 1

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

    NCT02962440

    Nov 2016 to Jan 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • somapacitanDrug

Arms1

  • Experimental

    Somapacitan

Primary outcomes3

Outcomes the sponsor listed as primary.

  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(2)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2021

14 results

Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects.

Helleberg et al. 2021European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciencescited by 12

PMID 34601071DOI 10.1016/j.ejps.2021.106030PUB-34601071

Full text at the publisher14 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 45 Years up to 64 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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