Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.

Inclusion Criteria:

• Men, women of non childbearing potential or women of child bearing potential who either abstain from sexual intercourse, have a sterile partner or practice a medically approved double barrier method of contraception
• Diagnosis of acromegaly of pituitary origin
• Have age adjusted Insulin like Growth Factor 1 (IGF-1) concentrations ≥1.5 times the upper limit of normal range on two consecutive measurements in the 6 months prior to the first dosing day (including the measurement to be made at screening [Visit 2])
• Have a random hGH level of ≥5 µg/L in the 6 months prior to or at screening (Visit 2)
• Have given written informed consent
• Ability to comply with the requirements of the protocol of the study

Exclusion Criteria:

• Previous specific treatment for acromegaly in the 6 months prior to screening (Visit 2), including somatostatin analogues (SSAs), surgery, radiotherapy and pegvisomant
• Treatment with dopamine agonists in the 3 months prior to screening (Visit 2)
• Uncontrolled hypertension or orthostatic hypotension
• Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin [HbA1c]≥7.5%) and patients requiring insulin treatment
• Gallstones or gravel that could cause biliary obstruction
• Hyperprolactinaemia
• Participation in a clinical study within 60 days prior to screening (Visit 2)
• Receipt of blood, blood products or plasma derivatives 60 days prior to screening (Visit 2)
• Pregnancy or lactation
• A history of active alcohol abuse or drug addiction
• Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
• Evidence or suspicion of tumour expansion
• Clinically significant abnormality in screening ECG
• Any clinically significant abnormal laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
• Any disease which in the Investigator's opinion would exclude the patient from the study