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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: Norditropin SimpleXx sc bolus injection
    • Single sc bolus injection of 3 mg growth hormone without interval exercise
  • Other: Norditropin SimpleXx single sc injection
    • Single sc bolus injection of 3 mg growth hormone with interval exercise
  • Other: Norditropin SimpleXx contin. sc infusion
    • Continuous sc infusion of 3 mg growth hormone without interval exercise
  • Other: Norditropin SimpleXx cont. sc infusion
    • Continuous sc infusion of 3 mg growth hormone with interval exercise

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Collaborator
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jurgita Janukonyte, Medical doctor – Aarhus University Hospital
  • Overall Official(s)
    • Torben Laursen, professor, Principal Investigator, Institute of Pharmacology, Aarhus University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.