Healthy CholecystectomizedPhase 1NCT00432068
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
A Phase 1 study testing Octreotide pamoate in people with Healthy Cholecystectomized, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Cholecystectomized
- What is being tested?
- Octreotide pamoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jan 2007to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
France3 sites
Novartis Investigative Site
Lagord
Novartis Investigative Site
Paris
Novartis Investigative Site
Rennes
Belgium2 sites
Novartis Investigative Site
Ghent
Novartis Investigative Site
Wavre-Gelgique
About this study
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
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.
- Conditions
- Healthy Cholecystectomized
- Being tested
- Octreotide pamoate
- Keywords
- Healthy volunteers, octreotide pamoate, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide pamoateDrug
| Study group | Role | What they receive |
|---|---|---|
| Octreotide pamoate | Experimental | Not described Receives: Drug: Octreotide pamoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate
Measured: 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.
Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring
Measured: 48 hrs post study drug administration
Secondary outcomes (1)
To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy CholecystectomizedStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432068
- Sponsor's protocol ID
- CSMS995K2101
- Status last verified
- Dec 2015
- First submitted
- 5 Feb 2007
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00432068
- Acronym / sponsor ID
- CSMS995K2101
- Conditions
- Healthy Cholecystectomized
- Keywords
- Healthy volunteers, octreotide pamoate, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octreotide pamoate | Experimental | Drug: Octreotide pamoate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide pamoate | Drug | Octreotide pamoate |
Primary outcome
Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate
Time frame: 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.
Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring
Time frame: 48 hrs post study drug administration
1 secondary outcome
To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Octreotide pamoate in people with Healthy Cholecystectomized, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.