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Trial record 5 of 1565 for:    Slovakia

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 : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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 Type : Interventional  (Clinical Trial)
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 : August 16, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Incidence of adverse events [ Time Frame: From first dosing to Day 43 ]
    Count

  4. Occurrence of anti-somapacitan antibodies [ Time Frame: From Day 0 to Day 43 ]
    Count



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212131


Locations
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 83101
Sponsors and Collaborators
Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03212131     History of Changes
Other Study ID Numbers: NN8640-4298
U1111-1187-9247 ( Other Identifier: World Health Organization (WHO) )
2016-003911-36 ( Registry Identifier: EudraCT )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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:
Endocrine System Diseases
Dwarfism, Pituitary
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