Back to resultsInvestigation 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.
Primary Purpose
Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
Status
Completed
Phase
Phase 1
Locations
Slovakia
Study Type
Interventional
Intervention
Somapacitan
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal hepatic function
Mild hepatic impairment
Moderate hepatic impairment
Arm Description
Subjects with normal hepatic function
Subjects with mild hepatic impairment
Subjects with moderate hepatic impairment
Outcomes
Primary Outcome Measures
Area under the somapacitan serum concentration time curve
Calculated based on somapacitan measured in blood
Secondary Outcome Measures
Maximum serum concentration of somapacitan
Calculated based on plasma somapacitan activity measured in blood
Time to maximum serum concentration of somapacitan
Calculated based on plasma somapacitan activity measured in blood
Incidence of adverse events
Count
Occurrence of anti-somapacitan antibodies
Count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03212131
Brief 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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
March 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal hepatic function
Arm Type
Experimental
Arm Description
Subjects with normal hepatic function
Arm Title
Mild hepatic impairment
Arm Type
Experimental
Arm Description
Subjects with mild hepatic impairment
Arm Title
Moderate hepatic impairment
Arm Type
Experimental
Arm Description
Subjects with moderate hepatic impairment
Intervention Type
Drug
Intervention Name(s)
Somapacitan
Intervention Description
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Primary Outcome Measure Information:
Title
Area under the somapacitan serum concentration time curve
Description
Calculated based on somapacitan measured in blood
Time Frame
From time 0 to 168 hours after the last dosing on Day 15
Secondary Outcome Measure Information:
Title
Maximum serum concentration of somapacitan
Description
Calculated based on plasma somapacitan activity measured in blood
Time Frame
After the last dosing on Day 15 until Day 43
Title
Time to maximum serum concentration of somapacitan
Description
Calculated based on plasma somapacitan activity measured in blood
Time Frame
After the last dosing on Day 15 until Day 43
Title
Incidence of adverse events
Description
Count
Time Frame
From first dosing to Day 43
Title
Occurrence of anti-somapacitan antibodies
Description
Count
Time Frame
From Day 0 to Day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Citations:
PubMed Identifier
33754315
Citation
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.
Results Reference
derived
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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.
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