Single Dose Pharmacology Study of DG317… | Clinical Trial

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide

Drug

Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.

DG3173

Drug

Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.

Primary outcomes

Participants With Trough Human Growth Hormone < 2.5 ug/mL

Time frame: Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.

Sponsors and collaborators

Lead sponsor

Aspireo Pharmaceuticals Limited

Industry

Registry information

Official study title

A Study of the Effect of Ascending Single Doses of DG3173 and 300 μg of Octreotide on Human Growth Hormone Levels in Untreated Acromegalics.

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2014
First posted: Sep 10, 2014
Registry last updated: Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed