Open Label Study of Octreotide Implant in Patients With Acromegaly

An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly

To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.

An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30 male and female patients with acromegaly. Eligible patients received 1 implant, either hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone (GH), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.

Inclusion Criteria:

• Male and female patients with acromegaly
• Must be at least 18 years old
• Confirmed diagnosis of a growth hormone -secreting tumor
• Must be either a full or partial responder to octreotide demonstrated by historical laboratory values

Exclusion Criteria:

• Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control
• Patients with liver disease
• Patients with symptomatic cholelithiasis
• Patients receiving radiotherapy for their pituitary tumor at any time before Screening