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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
octreotide
DG3173
Sponsored by
Aspireo Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Octreotide, then ascending DG3173

    Arm Description

    Interventions: octreotide and DG3173. 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.

    Outcomes

    Primary Outcome Measures

    Participants With Trough Human Growth Hormone < 2.5 ug/mL

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2014
    Last Updated
    January 19, 2018
    Sponsor
    Aspireo Pharmaceuticals Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02235987
    Brief Title
    Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.
    Official 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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Aspireo Pharmaceuticals Limited

    4. Oversight

    5. Study Description

    Brief Summary
    The study is designed to investigate the safety, tolerability and efficacy of DG3173 in untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of DG3173 as well as octreotide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acromegaly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Octreotide, then ascending DG3173
    Arm Type
    Other
    Arm Description
    Interventions: octreotide and DG3173. 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.
    Intervention Type
    Drug
    Intervention Name(s)
    octreotide
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    DG3173
    Intervention Description
    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 Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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