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Completed

NCT Number: NCT00931476

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.

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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 Healthy Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Honolulu, Hawaii, 96814-4224, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed informed consent before any trial related activities
  • Japanese and Caucasian males respectively
  • Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
  • Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

Treatment and study plan

Somatropin

Drug

Placebo

Drug

Primary outcomes

  1. Area under the hGH concentration-time curve (GH AUC0-24h)

    Time frame: from 0 to 24 hours following injection

  2. Maximum hGH concentration (GH Cmax)

    Time frame: from 0 to 24 hours following injection

  3. Treatment Emergent Adverse Events

    Time frame: from 0 to 24 hours following injection

Secondary outcomes

  1. Time to maximum hGH concentration (GH tmax)

  2. Area under the hGH concentration-time curve GH AUC0-∞)

  3. Elimination half-life (GH t½)

  4. Growth Factors (IGF-I and IGFBP-3)

  5. Non-treatment Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Jul 2, 2009
Registry last updated
Feb 27, 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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