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Completed

NCT Number: NCT00715689

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

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

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, København Ø, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC126-0083

Drug

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

Placebo

Drug

Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Primary outcomes

  1. Safety and tolerability (adverse events, local tolerability, physical examination)

    Time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary outcomes

  1. Cmax, maximum concentration of IGF-I

    Time frame: after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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