Clinical trial NCT02217800: The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
Official title: The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Lead sponsor: Aspireo Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.
timeFrame: 23 hours following each treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: