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

• Sponsor: Aspireo Pharmaceuticals Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02235987
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 18

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: octreotide; Drug: DG3173	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: Octreotide, then ascending DG3173 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.

Drug: octreotide; 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.; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Participants With Trough Human Growth Hormone < 2.5 ug/mL [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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aspireo Pharmaceuticals Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aspireo Pharmaceuticals Limited
• ClinicalTrials.gov Identifier: NCT02235987
• Other Study ID Numbers: DG3173-II-01
• First Posted: Sep 10, 2014
• Last Update Posted: Feb 15, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Acromegaly; Octreotide

Study Results

Participant Flow

Arm/Group Title	Octreotide, Then Ascending DG3173
Arm/Group 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.
Period Title: Overall Study
STARTED	20
Received Octreotide	20
Received 100 µg DG3173	20
Received 300 µg DG3173	20
Received 900 µg DG3173	19
Received 1800 µg DG3173	19
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Cross-over
Arm/Group 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.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (11.5)
Sex: Female, Male (Count of Participants)
Female	18 90%
Male	2 10%
Region of Enrollment (participants) [Number]
Ukraine	20 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.

Arm/Group Title	Baseline (Untreated Control)	300 µg Octreotide	100 µg DG3173	300 µg DG3173	900 µg DG3173	1800 µg DG3173
Arm/Group Description
Measure Participants	20	20	20	20	19	19
Number [participants with trough hGH < 2.5 µg/mL]	1 5%	8 NaN	4 NaN	6 NaN	7 NaN	8 NaN

Adverse Events

Arm/Group Title	300 µg Octreotide		100 µg DG3173		300 µg DG3173		900 µg DG3173		1800 µg DG3173
Arm/Group Description
All Cause Mortality
	300 µg Octreotide		100 µg DG3173		300 µg DG3173		900 µg DG3173		1800 µg DG3173
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	300 µg Octreotide		100 µg DG3173		300 µg DG3173		900 µg DG3173		1800 µg DG3173
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	300 µg Octreotide		100 µg DG3173		300 µg DG3173		900 µg DG3173		1800 µg DG3173
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		1/19 (5.3%)
Gastrointestinal disorders
abdominal pain	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/19 (5.3%)
Metabolism and nutrition disorders
Hyperamylasemia	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/19 (0%)
Nervous system disorders
Encephalopathy	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.