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.

NCT03212131 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN8640-4298U1111-1187-92472016-003911-36
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximum serum concentration of somapacitan

  After the last dosing on Day 15 until Day 43

• Time to maximum serum concentration of somapacitan

  After the last dosing on Day 15 until Day 43

• Incidence of adverse events

  From first dosing to Day 43

• Occurrence of anti-somapacitan antibodies

  From Day 0 to Day 43

Study Arms (3)

Normal hepatic function

EXPERIMENTAL

Subjects with normal hepatic function

Drug: Somapacitan

Mild hepatic impairment

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: Somapacitan

Moderate hepatic impairment

EXPERIMENTAL

Subjects with moderate hepatic impairment

Drug: Somapacitan

Interventions

Somapacitan DRUG

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

Mild hepatic impairment; Moderate hepatic impairment; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bratislava, 83101, Slovakia

Location

Related Publications (1)

• Bentz Damholt B, Dombernowsky SL, Dahl Bendtsen M, Bisgaard C, Hojby Rasmussen M. Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. Clin Pharmacokinet. 2021 Aug;60(8):1015-1027. doi: 10.1007/s40262-021-00990-7. Epub 2021 Mar 23.

  PMID: 33754315 DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitan

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: August 16, 2017
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)