Trial · Interventional

CompletedPhase 1Registry data

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

NCTNCT03212131Other idNN8640-4298Other idU1111-1187-9247Other id2016-003911-36Other id2016

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 34 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Slovakia
Start: 16 Aug 2017
Primary completion: 8 Mar 2018
Completion: 8 Mar 2018
First posted: 11 Jul 2017
Last update posted: 24 May 2019
Conditions: Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 1
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
NCT03212131
16 Aug 2017 to 8 Mar 2018

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 this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics). In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.

Interventions

SomapacitanDrug

Arms3

Experimental
Normal hepatic function
Subjects with normal hepatic function
Experimental
Mild hepatic impairment
Subjects with mild hepatic impairment
Experimental
Moderate hepatic impairment
Subjects with moderate hepatic impairment

Primary outcomes1

Outcomes the sponsor listed as primary.

Area under the somapacitan serum concentration time curve
Time frame · From time 0 to 168 hours after the last dosing on Day 15
Registry description
Calculated based on somapacitan measured in blood

Secondary outcomes(4)

Maximum serum concentration of somapacitan
Time frame · After the last dosing on Day 15 until Day 43
Registry description
Calculated based on plasma somapacitan activity measured in blood
Time to maximum serum concentration of somapacitan
Time frame · After the last dosing on Day 15 until Day 43
Registry description
Calculated based on plasma somapacitan activity measured in blood
Incidence of adverse events
Time frame · From first dosing to Day 43
Registry description
Count
Occurrence of anti-somapacitan antibodies
Time frame · From Day 0 to Day 43
Registry description
Count

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: Randomized controlled trial · 2021

9 results

Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials.

Bentz Damholt et al. 2021Clinical pharmacokineticscited by 4

PMID 33754315PMC8332591DOI 10.1007/s40262-021-00990-7PUB-33754315

Free to read · publisher termsCC BY-NC9 results

Read at source See results (9)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female aged 18-75 years (both inclusive) * Body mass index of 18.5-39.9 kg/sqm (both inclusive) * Subjects with normal hepatic function or hepatic impairment (mild or moderate) Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration * Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration * 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 * Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol

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