Healthy SubjectsPhase 1NCT00757367
A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)
A Phase 1 study testing TI Inhalation Powder in people with Healthy Subjects, run by Mannkind Corporation at 1 site in United States.
Trial summary
Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is aspirated out to remove any remaining TI. It's performed twice at specific time points in 12 healthy volunteers. BAL fluid will be analyzed for insulin and FDKP. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TI Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmokers for greater than or equal to 12 months
- Normal chest x-ray (CXR) at Screening/Visit 1
- Prebronchodilator FEV1 greater than or equal to 80% Third National Health and Nutrition Examination Survey (NHANES) III Predicted
- Prebronchodilator FEV1/FVC greater than or equal to LLN% NHANES III Predicted
- Prebronchodilator total lung capacity (TLC) greater than or equal to 80% of Predicted Intermountain Thoracic Society (ITS)
- Prebronchodilator Dlco (unc) greater than or equal to 80% Predicted (Miller)
- Written Informed Consent
Who cannot join
- History of diabetes mellitus
- Previous exposure to TI Inhalation Powder within 3 months of Visit 1, or exposure to any other inhaled insulin product
- Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure.
- History of chronic obstructive pulmonary disease (COPD), asthma, and or any other clinically important pulmonary disease (eg, cystic fibrosis, bronchiectasis, and/or sleep apnea) confirmed by PFTs and/or radiologic findings.
- Known allergic or adverse reactions to specified medications
- Seizure disorder, significant cardiovascular dysfunction and/or history within 3 months of Visit 1, uncontrolled hypertension, known history of aortic or cerebral aneurysm, renal dysfunction or disease, serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females and/or blood urea nitrogen (BUN) > 50 mg/dL
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- Cancer (other than excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms.
- History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes, as evidenced by serum aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) ? 3x upper limit of normal (ULN).
- Active infection (eg, human immunodeficiency virus (HIV), hepatitis) or history of severe infection within 30 days of Visit 1
- Anemia (hemoglobin value ? 10.5 g/dL for females or ? 11.5 g/dL for males.
- Diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine.
- Current or previous chemotherapy, radiation therapy, or amiodarone use that may result in pulmonary toxicity.
- Clinically significant abnormalities or screening laboratory evaluation (unless approved by the Medical Monitor).
- Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period.
- Female subjects of childbearing potential not practicing adequate birth control.
- Current drug or alcohol abuse or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial.
- Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial while participating in the clinical trial.
- Unable and/or unlikely to comprehend and/or follow the trial protocol.
- Unable and/or unlikely to comprehend how to use the MedTone Inhaler Model D or inability to properly use the device.
- A lack of compliance with medication or procedures, that, in the PI's opinion, may affect the clinical trial data or the subject's safety and which precludes the subject from further participation in the clinical trial
- Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent, and/or impair the subject's ability to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Controlled Clinical Trial to Determine the Pulmonary Residence Time of Insulin and Fumaryl Diketopiperazine, Utilizing Bronchoalveolar Lavage, After Administration of Technosphere® Insulin Inhalation Powder in Healthy Subjects
Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is aspirated out to remove any remaining TI. It's performed twice at specific time points in 12 healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.
Read the detailed description
Informed consent and eligibility occur at Screening. Dosing is at Visit 2. Blood glucose levels are monitored and adjusted using IV infusion of glucose. Bronchoalveolar lavage (BAL) is performed at 30 minutes and 6 hours for Cohort 1 and at 4 and 8 hours for Cohort 2, post TI dose. A series of blood samples are taken at specified timepoints. Cohort 3 will proceed with dosing if deemed necessary once analysis of BAL from Cohorts 1 \& 2 is performed. Visit 3 is the follow-up safety visit.
- Conditions
- Healthy Subjects
- Being tested
- TI Inhalation Powder
- Keywords
- Healthy subjects, insulin, bronchoscope, serum insulin, serum C-Peptide, BAL fluid, FDKP
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI Inhalation PowderDrug
1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| TI Inhalation Powder | Experimental | TI Inhalation Powder, single dose, 60 units Receives: Drug: TI Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, MD, MPH, Study chair, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757367
- Sponsor's protocol ID
- MKC-TI-122
- Status last verified
- Dec 2013
- First submitted
- 22 Sep 2008
- Last updated
- 17 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Controlled Clinical Trial to Determine the Pulmonary Residence Time of Insulin and Fumaryl Diketopiperazine, Utilizing Bronchoalveolar Lavage, After Administration of Technosphere® Insulin Inhalation Powder in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00757367
- Acronym / sponsor ID
- MKC-TI-122
- Conditions
- Healthy Subjects
- Keywords
- Healthy subjects, insulin, bronchoscope, serum insulin, serum C-Peptide, BAL fluid, FDKP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Sep 2008 (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.
Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is aspirated out to remove any remaining TI. It's performed twice at specific time points in 12 healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.
Detailed description
Informed consent and eligibility occur at Screening. Dosing is at Visit 2. Blood glucose levels are monitored and adjusted using IV infusion of glucose. Bronchoalveolar lavage (BAL) is performed at 30 minutes and 6 hours for Cohort 1 and at 4 and 8 hours for Cohort 2, post TI dose. A series of blood samples are taken at specified timepoints. Cohort 3 will proceed with dosing if deemed necessary once analysis of BAL from Cohorts 1 \& 2 is performed. Visit 3 is the follow-up safety visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TI Inhalation Powder | Experimental | Drug: TI Inhalation PowderTI Inhalation Powder, single dose, 60 units |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nonsmokers for greater than or equal to 12 months
- Normal chest x-ray (CXR) at Screening/Visit 1
- Prebronchodilator FEV1 greater than or equal to 80% Third National Health and Nutrition Examination Survey (NHANES) III Predicted
- Prebronchodilator FEV1/FVC greater than or equal to LLN% NHANES III Predicted
- Prebronchodilator total lung capacity (TLC) greater than or equal to 80% of Predicted Intermountain Thoracic Society (ITS)
Key exclusion criteria (21 listed)
- History of diabetes mellitus
- Previous exposure to TI Inhalation Powder within 3 months of Visit 1, or exposure to any other inhaled insulin product
- Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure.
- History of chronic obstructive pulmonary disease (COPD), asthma, and or any other clinically important pulmonary disease (eg, cystic fibrosis, bronchiectasis, and/or sleep apnea) confirmed by PFTs and/or radiologic findings.
- Known allergic or adverse reactions to specified medications
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 |
|---|---|---|
| TI Inhalation Powder1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2. | Drug | TI Inhalation Powder |
Primary outcome
Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder.
Time frame: 2 Months
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 17 Dec 2013.
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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.
Anders Boss, MD, MPH study chair
Mannkind Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TI Inhalation Powder in people with Healthy Subjects, run by Mannkind Corporation at 1 site in United States.
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 7 inclusion and 21 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder. (time frame: 2 Months). 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 17 Dec 2013.