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.

Adult Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212131
• Other study ID #: NN8640-4298
• Secondary ID: U1111-1187-92472
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: May 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder

Intervention

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

Locations

Country	Name	City	State
Slovakia	Novo Nordisk Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the somapacitan serum concentration time curve	Calculated based on somapacitan measured in blood	From time 0 to 168 hours after the last dosing on Day 15
Secondary	Maximum serum concentration of somapacitan	Calculated based on plasma somapacitan activity measured in blood	After the last dosing on Day 15 until Day 43
Secondary	Time to maximum serum concentration of somapacitan	Calculated based on plasma somapacitan activity measured in blood	After the last dosing on Day 15 until Day 43
Secondary	Incidence of adverse events	Count	From first dosing to Day 43
Secondary	Occurrence of anti-somapacitan antibodies	Count	From Day 0 to Day 43