Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

February 6, 2017 updated by: Novo Nordisk A/S

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København Ø, Denmark, 2100
        • Novo Nordisk INvestigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk INvestigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
  • Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
  • GH replacement therapy for more than 3 months
  • Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Malignant disease
  • Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
  • Heart insufficiency, NYHA class greater than 2
  • Subjects with diabetes with an HbA1C above 8.0%
  • Diabetic receiving insulin treatment
  • Stable pituitary replacement therapy for less than 3 months
  • Impaired liver function
  • Impaired kidney function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
EXPERIMENTAL: A
Drug: NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
EXPERIMENTAL: C
Drug: NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
EXPERIMENTAL: D
Drug: NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Other Names:
  • pegylated long-acting human growth hormone
Drug: placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability (adverse events, local tolerability, physical examination)
Time Frame: 0 to 10 days after third dosing, (day 15-25 after first dose)
0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax, maximum concentration of IGF-I
Time Frame: after trial product administration
after trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (ESTIMATE)

July 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8630-1823
  • 2008-001061-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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