Current partner codePEPTIDESDE
NCT03212131·Phase 1·INTERVENTIONAL

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.

Status

Completed

Phase

Phase 1

Enrollment

34

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Somapacitan

3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg

Timeline

From registration to results.

  1. First posted

    Jul 11, 2017

  2. Study start

    Aug 16, 2017

  3. Primary completion

    Mar 8, 2018

  4. Study completion

    Mar 8, 2018

  5. Results posted

    Not reported

  6. Registry updated

    May 24, 2019

Outcomes

What the study measures.

Primary outcomes

Area under the somapacitan serum concentration time curve

Time frame · From time 0 to 168 hours after the last dosing on Day 15

Calculated based on somapacitan measured in blood

Secondary outcomes

Maximum serum concentration of somapacitan

Time frame · After the last dosing on Day 15 until Day 43

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

Calculated based on plasma somapacitan activity measured in blood

Incidence of adverse events

Time frame · From first dosing to Day 43

Count

Occurrence of anti-somapacitan antibodies

Time frame · From Day 0 to Day 43

Count

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

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

Novo Nordisk Investigational Site

Bratislava, Slovakia

Related trials

More studies on Somapacitan.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.