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.

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03212131
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children	Drug: Somapacitan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 16, 2017
• Actual Primary Completion Date: Mar 8, 2018
• Actual Study Completion Date: Mar 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal hepatic function Subjects with normal hepatic function	Drug: Somapacitan; 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Experimental: Mild hepatic impairment Subjects with mild hepatic impairment	Drug: Somapacitan; 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Experimental: Moderate hepatic impairment Subjects with moderate hepatic impairment	Drug: Somapacitan; 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg

Outcome Measures

Primary Outcome Measures

1. 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

1. Maximum serum concentration of somapacitan [After the last dosing on Day 15 until Day 43]

   Calculated based on plasma somapacitan activity measured in blood

2. 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

3. Incidence of adverse events [From first dosing to Day 43]

   Count

4. Occurrence of anti-somapacitan antibodies [From Day 0 to Day 43]

   Count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Bratislava		Slovakia	83101

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03212131
• Other Study ID Numbers: NN8640-4298; U1111-1187-9247; 2016-003911-36
• First Posted: Jul 11, 2017
• Last Update Posted: May 24, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases

Study Results

No Results Posted as of May 24, 2019