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.

Phase 1

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children
• Interventions: Drug: Somapacitan

• Registration Number: NCT03212131
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-08-16
• Primary Completion: 2018-03-08
• Study Completion: 2018-03-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate hepatic impairment	Somapacitan	Subjects with moderate hepatic impairment
Normal hepatic function	Somapacitan	Subjects with normal hepatic function
Mild hepatic impairment	Somapacitan	Subjects with mild hepatic impairment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia