Acromegaly
Conditions
Keywords
Acromegaly
Brief summary
The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.
Interventions
DRUGOctreotide acetate prolonged release, 30 mg
Administered by deep IM (gluteus) on Days 1, 28 and 56
DRUGC2L-OCT-01 PR, 30 mg
Administered by deep IM injection (gluteus) on days 1 and 42
Sponsors
Ambrilia Biopharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be diagnosed with active acromegaly. * If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry. * If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry. * If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable. * If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age. * If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication. * The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.
Exclusion criteria
* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating. * Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry. * Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study * Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients * Subject who have any other condition that alters the growth hormone or IGF-1 levels. * Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg | Days 1, 28, 42, 56 and 84 |
Secondary
| Measure | Time frame |
|---|---|
| Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR | 84 days |
Countries
Belarus, Hungary, Romania, Serbia, Slovakia, Ukraine
Outcome results
None listed