Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: BIM23B065
Intervention description: Subcutaneous twice a day or three times a day administration of BIM23B065. Dose will be 0.4, 0.6, 0.8 or 1 mg (twice a day or three times a day).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is evaluate the safety, the pharmacodynamics and the
      pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided written informed consent prior to any study related procedures.

          -  Subjects will have a documented diagnosis of acromegaly.

          -  Subjects will have active acromegaly confirmed by a mean serum concentration of GH
             over 2 hours > 2.5 µg/L at screening analysed by central laboratory.

          -  Subjects who have had pituitary surgery must be >8 weeks post-surgery.

          -  18 to 75 years of age.

          -  Negative pregnancy test (female subjects).

          -  Female who is either of non-childbearing potential or who is not pregnant at screening
             and agrees to use highly effective contraception during whole duration of the study.
             Non-childbearing potential is defined as being postmenopausal for at least 1 year, or
             women with documented infertility (natural or acquired).

          -  Male subjects must agree that, if their partner is at risk of becoming pregnant, they
             will use a medically accepted, effective method of contraception (i.e. condom) for the
             duration of the treatment period of the study.

        Exclusion Criteria:

          -  The subject has received long-acting Somatostatin Analogues (SSA) within 12 weeks
             prior screening (e.g.octreotide long acting release (LAR), lanreotide Autogel,
             pasireotide LAR).

          -  The subject has received short-acting SSA within 1 week (e.g. octreotide SC) prior to
             screening.

          -  The subject has received a dopamine agonist within 6 weeks (e.g., bromocriptine or
             cabergoline) prior to screening.

          -  The subject has received GH antagonist within 12 weeks prior to screening (e.g.,
             pegvisomant).

          -  The subject had undergone radiotherapy to the pituitary gland at any time prior to
             study entry.

          -  It is anticipated that the subject will undergo pituitary surgery or radiation to the
             pituitary gland during the study, or will require additional medical therapy for
             acromegaly (including SSA, pegvisomant, or dopamine agonists) during the study.

          -  The subject has unsubstituted/untreated adrenal insufficiency.

          -  If the subject has any history of postural hypotension or evidence of postural
             hypotension at screening (>= 20 mm Hg decrease in Systolic blood pressure (SBP), >= 10
             mm Hg decrease in diastolic blood pressure, or >=30 bpm increases in pulse rate, after
             standing for 2 minutes from resting supine position of at least 10 min).

          -  Subject with poorly controlled diabetes mellitus (presence of ketoacidosis or a
             glycosylated hemoglobin level >10%).

          -  Subject with diabetes treated with insulin for less than 6 weeks prior to study entry,
             or with an unstable insulin dose in the 6 weeks prior to study entry or HbA1c>10%.

          -  Subject is taking beta-blockers (which can inhibit compensatory increases in HR during
             hypotensive episodes).

          -  Subject is being treated for hypertension and in the opinion of the investigator their
             antihypertensive medication puts them at increased risk of postural hypotension.

          -  Subject is hypotensive at screening as defined as systolic < 90 mmHg and/or diastolic
             <60 mmHg.

          -  Subject has clinically significant hepatic abnormalities and/or alanine
             aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2 x ULN and/or
             alkaline phosphatase (AP) ≥2 x ULN and/or total bilirubin ≥1.5 x ULN and
             gamma-glutamyl transferase (GGT) ≥2.5 x ULN during the Screening period (local
             laboratory results).

          -  Subject has a compression of the optic chiasm causing visual-field defects.

          -  Subject is receiving any oestrogen-containing Hormone Replacement Therapy (HRT).

          -  Subject has clinically significant pancreatic abnormalities and/or amylase and/or
             lipase ≥2 x ULN during the Screening period (local laboratory results).

          -  Any significant renal abnormalities, including confirmed proteinuria and/or creatinine
             ≥1.5x ULN during screening assessed by the local laboratory.