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

NCT01090778 | Completed Phase 2 DMC

• 1 other identifier: 2010/0121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Growth Hormone Deficiency

Keywords

growth hormone deficiency; circadian variation

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profiles of growth hormone

  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.

  48 hours

Secondary Outcomes (1)

• Pharmacokinetic profiles of growth hormone

  60 hours

Study Arms (4)

Norditropin SimpleXx sc bolus injection

OTHER

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

Drug: Norditropin SimpleXx (growth hormone)

Norditropin SimpleXx single sc injection

OTHER

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

Drug: Norditropin SimpleXx (growth hormone)

Norditropin SimpleXx contin. sc infusion

OTHER

Continuous sc infusion of 3 mg growth hormone without interval exercise

Drug: Norditropin SimpleXx (growth hormone)

Norditropin SimpleXx cont. sc infusion

OTHER

Continuous sc infusion of 3 mg growth hormone with interval exercise

Drug: Norditropin SimpleXx (growth hormone)

Interventions

Norditropin SimpleXx (growth hormone) DRUG

3mg/subject/day over two consecutive days

Also known as: Norditropin® SimpleXx®

Norditropin SimpleXx cont. sc infusion; Norditropin SimpleXx contin. sc infusion; Norditropin SimpleXx sc bolus injection; Norditropin SimpleXx single sc injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Medical Department M, Aarhus University Hospital

Aarhus C, Central Jutland, 8000, Denmark

Location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Torben Laursen, professor

  Institute of Pharmacology, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 23, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

DK (2)