Clinical trial NCT00432068: Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Official title: A Phase I , Open Label, Single Center, Dose Escalation Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of a New Extended Long-acting Formulation of Octreotide Pamoate Administered i.m. in Healthy Cholecystectomized Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Cholecystectomized
Keywords: Healthy volunteers
octreotide pamoate
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide extended long-acting formulation after a single dose in humans. It will investigate the profile of a single dose of drug in a healthy volunteer subject in order to understand the timing and extent of fluctuations in octreotide concentrations in the blood with this formulation, the relationship of drug concentration with dose, and how long the drug remains in the body system.


Eligibility criteria: Inclusion criteria:

* Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study.
* In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening
* Body mass index within 19-29 kg/m2
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria:

* Any clinically significant abnormal laboratory values at screening, or evidence of clinically significant abnormal findings at the physical exam at screening, or significant illness within 2 weeks prior to dosing
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated)
* History of clinically significant drug allergy, history of atopic allergy, history or clinical evidence of pancreatic injury or pancreatitis, clinical evidence of liver disease or liver injury , history or presence of impaired renal function, or history of urinary obstruction or difficulty urinating
* History of immunocompromise, including a positive HIV
* Known positive hepatitis B or C surface antigen (HBsAg) or Hepatitis C test result (anti-HCV)
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays at screening
* Female subjects who are pregnant or lactating, or are of childbearing potential and without a medically acceptable and highly effective method for birth control.
* Demonstrating intolerance to octreotide at baseline
* Any subject who has a known history of diabetes mellitus in parents or grandparents.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate
timeFrame: 30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose; Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart.
measure: Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring
timeFrame: 48 hrs post study drug administration
Secondary outcomes:
measure: To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate
timeFrame: 30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose. Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Novartis Investigative Site
city: Wavre-Gelgique
country: Belgium
facility: Novartis Investigative Site
city: Lagord
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Verona
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: