The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.

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

Details

• Lead Sponsor: Aspireo Pharmaceuticals Limited
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception

• Diagnosis of acromegaly of pituitary origin

• Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening

• Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening

• Have given written informed consent

• Ability to comply with the requirements of the protocol for the study

Exclusion Criteria:

• Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant

• Treatment with dopamine agonists in the 3 months prior to screening

• Uncontrolled hypertension

• 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

• Receipt of blood, blood products or plasma derivatives 60 days prior to screening

• Body mass index (BMI) below 22 or above 37 kg/m2

• Pregnancy, lactation or use of any hormonal based contraceptives

• Concomitant intake of corticosteroids or levodopa

• 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 in the opinion of the Investigator

• Any clinically significant abnormal in screening 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