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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hormones

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