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Completed

NCT Number: NCT01090778

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Department M, Aarhus University Hospital, Aarhus C, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Norditropin SimpleXx (growth hormone)

Drug

3mg/subject/day over two consecutive days

Other names: Norditropin® SimpleXx®

Primary outcomes

  1. Pharmacokinetic profiles of growth hormone

    Time frame: 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 outcomes

  1. Pharmacokinetic profiles of growth hormone

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Jan 9, 2014

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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