A trial to assess whether the new drug ATL1103 is safe and effective in patients who have acromegaly

• Conditions: Acromegaly; MedDRA version: 16.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-003147-30-HU
• Lead Sponsor: Antisense Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-14
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients who:
1.Provide written informed consent in accordance with local regulations.

2.Are 18 to 80 years of age inclusive.

3.Have acromegaly due to pituitary adenoma (micro or macro adenoma) identified by Magnetic Resonance Imaging (MRI).

4.Have serum Insulin-like growth factor-1 (IGF-1) levels at Screening >1.3 times the upper limit of normal.

5.Have nadir serum Growth Hormone (GH) levels > 1ng/mL at all test time points within the 2 hours post oral glucose load for an oral glucose tolerance test.

6.Are acromegaly treatment naïve, or who have not taken other acromegaly medications for the following periods of time prior to IGF-1 and GH Screening tests:
•Bromcriptine: 6 weeks
•Carbergoline: 8 weeks
•Quinagolide: 8 weeks
•Octreotide (subcutaneous): 4 weeks
•Pegvisomant: 8 weeks
•Octreotide LAR: 4 months
•Lanreotide (all presentations): 4 months
Note: patients on medications may washout after consenting.

7.Have a body mass index (BMI) =19 kg/m2.

8.Have adequate venous access to allow collection of multiple blood samples during the study.

9.Are female of non-child-bearing potential (i.e. either surgically sterilised or at least one year post-menopausal), or if of child-bearing potential, must agree to use two approved methods of contraception for the duration of the study and for three months after administration of the last dose of study drug

OR

Are male and surgically sterilized or agree to use an approved method of contraception for the duration of the study and until three months after administration of the last dose of the study medication.

10.Are willing and able to self-administer subcutaneous injections.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Patients who:
1.Have acromegaly due to reasons other than pituitary adenoma.

2.Have a pituitary adenoma that is less than 3mm distance from the optic chiasm.

3.Have undergone pituitary surgery within the 3 months preceding the Screening visit.

4.Have received pituitary radiotherapy within the 3 years preceding the Baseline visit.

5.Have insulin-treated diabetes.

6.Have congestive heart failure, unstable angina, clinically significant cardiac arrhythmia, or a history of acute myocardial infarction within the 3 months preceding the Baseline visit.

7.Have abnormal hepatic function at Screening defined as aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, prothrombin time or total bilirubin above 2 x the upper limit of normal.

8.Have hepatitis B, hepatitis C, or chronic liver disease.

9.Are pregnant or lactating.

10.Have known human immunodeficiency virus (not tested specifically for this protocol), or history of immunodeficiency that may compromise their safety or affect results from this study.

11.Have a history of alcohol or drug abuse in the 6 month period preceding the Baseline visit.

12.Have participated in any clinical investigation with an investigational drug within 3 months (4 months if the drug is a new chemical entity) preceding the Baseline visit or during the washout period.

13.Have renal impairment with serum creatinine > or = 2.0 mg/dl (177 µmol/L).

14.Have a history of clinically relevant gastrointestinal, hepatic, renal, endocrine (other than acromegaly), haematological, metabolic, neurologic or psychiatric disease that in the investigator’s opinion may compromise their safety or effect results from this study.

15.Have a history of clinically significant coagulation abnormalities or complement fragment Bb abnormalities.

16.Have a history of severe or life-threatening drug allergy and/or known drug hypersensitivity.

17.Are unable to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function.

18.Have any other medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study, or are otherwise unsuitable for participation.

19.Are unable to have a MRI performed due to metal residing in the body e.g. implants, cardiac pacemaker, valves, cochlear implants, central nervous system vascular clips etc.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified