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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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ClinicalTrials.gov Identifier: NCT03212131
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
Area under the somapacitan serum concentration time curve [ Time Frame: From time 0 to 168 hours after the last dosing on Day 15 ]
Calculated based on somapacitan measured in blood
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03212131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Maximum serum concentration of somapacitan [ Time Frame: After the last dosing on Day 15 until Day 43 ]
    Calculated based on plasma somapacitan activity measured in blood
  • Time to maximum serum concentration of somapacitan [ Time Frame: After the last dosing on Day 15 until Day 43 ]
    Calculated based on plasma somapacitan activity measured in blood
  • Incidence of adverse events [ Time Frame: From first dosing to Day 43 ]
    Count
  • Occurrence of anti-somapacitan antibodies [ Time Frame: From Day 0 to Day 43 ]
    Count
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Growth Hormone Deficiency in Children
Intervention  ICMJE Drug: Somapacitan
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Study Arms  ICMJE
  • Experimental: Normal hepatic function
    Subjects with normal hepatic function
    Intervention: Drug: Somapacitan
  • Experimental: Mild hepatic impairment
    Subjects with mild hepatic impairment
    Intervention: Drug: Somapacitan
  • Experimental: Moderate hepatic impairment
    Subjects with moderate hepatic impairment
    Intervention: Drug: Somapacitan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 8, 2018
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03212131
Other Study ID Numbers  ICMJE NN8640-4298
U1111-1187-9247 ( Other Identifier: World Health Organization (WHO) )
2016-003911-36 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novo Nordisk A/S
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP