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Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)

Sponsor
Aarhus University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01090778
Collaborator
Novo Nordisk A/S (Industry)
8
Enrollment
2
Locations
4
Arms
14
Duration (Months)
4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

Condition or Disease Intervention/Treatment Phase
  • Drug: Norditropin SimpleXx (growth hormone)
 Phase 2

Detailed Description

The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: Norditropin SimpleXx sc bolus injection

Single sc bolus injection of 3 mg growth hormone without interval exercise

Drug: Norditropin SimpleXx (growth hormone)
3mg/subject/day over two consecutive days
Other Names:
  • Norditropin® SimpleXx®

    		•
    Other: Norditropin SimpleXx single sc injection

    Single sc bolus injection of 3 mg growth hormone with interval exercise

    Drug: Norditropin SimpleXx (growth hormone)
    3mg/subject/day over two consecutive days
    Other Names:
  • Norditropin® SimpleXx®

    		•
    Other: Norditropin SimpleXx contin. sc infusion

    Continuous sc infusion of 3 mg growth hormone without interval exercise

    Drug: Norditropin SimpleXx (growth hormone)
    3mg/subject/day over two consecutive days
    Other Names:
  • Norditropin® SimpleXx®

    		•
    Other: Norditropin SimpleXx cont. sc infusion

    Continuous sc infusion of 3 mg growth hormone with interval exercise

    Drug: Norditropin SimpleXx (growth hormone)
    3mg/subject/day over two consecutive days
    Other Names:
  • Norditropin® SimpleXx®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic profiles of growth hormone [48 hours]

      Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.

    Secondary Outcome Measures

    1. Pharmacokinetic profiles of growth hormone [60 hours]

      To compare pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as an infusion in the adult patients with growth hormone deficiency during interval exercise or in supine rest.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • AGHD male or female subjects

    • Stable GH replacement therapy for at least 3 months

    • Body Mass Index 18,5 to 35.0 kg/m2

    • Achieved final height

    • Age ≥ 18 years

    Exclusion Criteria:

    • Known or suspected allergy to trial product or components of the trial product

    • Subjects with active malignancy

    • Severe cardiac insufficiency classified according to NYHA III-IV

    • Unstable angina pectoris, acute myocardial infarction within the last 12 months

    • Severe, uncontrolled hypertension: sitting blood pressure > 180/110 mmHg

    • HbA1C > 7,5 %

    • Impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital lab.

    • Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab.

    • Patients on insulin treatment

    • Stable pituitary replacement therapy for less than 3 months

    • Participation in any other clinical trial involving any investigational products within the last three months prior to this trial

    • Any diseases judged by the investigator that could affect the trial

    • Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, IUD or who had not undergone hysterectomy or sterilization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Department M, Aarhus University Hospital Aarhus C Central Denmark Region Denmark 8000
    2 Aarhus University Hospital Aarhus C Denmark 8000

    Sponsors and Collaborators

    • Aarhus University Hospital
    • Novo Nordisk A/S

    Investigators

    • Principal Investigator: Torben Laursen, professor, Institute of Pharmacology, Aarhus University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jurgita Janukonyte, Medical doctor, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT01090778
    Other Study ID Numbers:
    • 2010/0121
    First Posted:
    Mar 23, 2010
    Last Update Posted:
    Jan 9, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Jurgita Janukonyte, Medical doctor, Aarhus University Hospital
    growth hormone deficiency
    circadian variation
    Additional relevant MeSH terms:
    Dwarfism, Pituitary
    Endocrine System Diseases
    Hormones

    Study Results

    No Results Posted as of Jan 9, 2014