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Clinical Trials/NCT00715689
NCT00715689
Completed
Phase 2

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)

Novo Nordisk A/S1 site in 1 country33 target enrollmentJuly 2008
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ConditionsGrowth Hormone DisorderAdult Growth Hormone Deficiency
InterventionsplaceboNNC126-0083
DrugsNNC126-0083placebo

Overview

Phase
Phase 2
Intervention
placebo
Conditions
Growth Hormone Disorder
Sponsor
Novo Nordisk A/S
Enrollment
33
Locations
1
Primary Endpoint
Safety and tolerability (adverse events, local tolerability, physical examination)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
March 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
  • •Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
  • •GH replacement therapy for more than 3 months
  • •Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria

  • •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • •Malignant disease
  • •Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
  • •Heart insufficiency, NYHA class greater than 2
  • •Subjects with diabetes with an HbA1C above 8.0%
  • •Diabetic receiving insulin treatment
  • •Stable pituitary replacement therapy for less than 3 months
  • •Impaired liver function
  • •Impaired kidney function

Arms & Interventions

B

Intervention: placebo

A

Intervention: NNC126-0083

A

Intervention: placebo

B

Intervention: NNC126-0083

C

Intervention: NNC126-0083

C

Intervention: placebo

D

Intervention: NNC126-0083

D

Intervention: placebo

Outcomes

Primary Outcomes

Safety and tolerability (adverse events, local tolerability, physical examination)

Time Frame: 0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary Outcomes

  • Cmax, maximum concentration of IGF-I(after trial product administration)

Study Sites (1)

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