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.

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: Somapacitan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03212131

2016-003911-36 (Registry Identifier)

NN8640-4298

U1111-1187-9247 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Normal hepatic function

Experimental group

Description:

Subjects with normal hepatic function

Treatment:

Drug: Somapacitan

Mild hepatic impairment

Experimental group

Description:

Subjects with mild hepatic impairment

Treatment:

Drug: Somapacitan

Moderate hepatic impairment

Experimental group

Description:

Subjects with moderate hepatic impairment

Treatment:

Drug: Somapacitan