HealthyPhase 1NCT01490762
Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler
A Phase 1 study testing Technosphere Insulin Inhalation Powder using the Gen2C inhaler and Regular Human Insulin in people with Healthy, run by Mannkind Corporation at 1 site in United States.
Trial summary
This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Technosphere Insulin Inhalation Powder using the Gen2C inhaler and Regular Human Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- Good venous access for blood draws
- No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (< 100 ng/mL)
- Body mass index (BMI) < 32 kg/m2
- FEV1 = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- FVC = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
- Written informed consent provided
Who cannot join
- Blood donation of 500 mL within the previous 56 days
- Fasting blood sugar >130 mg/dL
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Allergy to study drug, food, or other study material (eg, peanuts, soy products)
- Clinically significant active or chronic illness
- History of asthma, COPD, or any other clinically relevant chronic lung disease
Show all 19Show fewer
- Respiratory tract infection within 4 weeks before screening
- Donation of blood within 3 months before screening
- History of drug or alcohol abuse
- Positive urine drug screen
- Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
- Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study
- Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin
- History of malignancy within the 5 years before screening (other than basal cell carcinoma)
- History of human immunodeficiency virus (HIV) infection or hepatitis B or C
- Women who are pregnant, lactating, or planning to become pregnant during the clinical study period
- Any subject who at Visit 2 has a blood glucose value = 150 mg/dL 2 hours after the meal, should be discussed with the MKC medical monitor and may be removed as potentially having impaired glucose tolerance
- Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder
- Women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research
Chula Vista, California, 91911
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Effect Following Inhalation of Technosphere® Insulin Inhalation Powder at Multiple Doses Using the Gen2C Inhaler
This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
Read the detailed description
Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler:
- 10 U (one 10 U cartridge)
- 30 U (one 10 U and one 20 U cartridge)
- 60 U (three 20 U cartridges)
- 80 U (four 20 U cartridges)
- Conditions
- Healthy
- Being tested
- Technosphere Insulin Inhalation Powder using the Gen2C inhaler, Regular Human Insulin
- Keywords
- PK, PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere Insulin Inhalation Powder using the Gen2C inhalerDrug
Inhalation Powder
Regular Human InsulinDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Regular Human Insulin | Active comparator | Subcutaneous injection Receives: Drug: Regular Human Insulin |
| TI and Regular Human Insulin | Experimental | All subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin Receives: Drug: Technosphere Insulin Inhalation Powder using the Gen2C inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
Measured: crossover 4 times over the course of up to 5 weeks
Secondary outcomes (3)
Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)
Timepoints: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after administration of TI dosing; 0, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480 and 600 minutes after RHI dosing
Measured: crossover 5 times over the course of up to 6 weeks
Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI
Timepoints for TI: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after TI dosing Timepoints: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480 and 600 minutes after RHI dosing
Measured: crossover 5 times over the course of up to 6 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Measured: crossover 5 times for up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490762
- Sponsor's protocol ID
- MKC-TI-176
- Status last verified
- Sep 2012
- First submitted
- 5 Dec 2011
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Effect Following Inhalation of Technosphere® Insulin Inhalation Powder at Multiple Doses Using the Gen2C Inhaler
- ClinicalTrials.gov ID
- NCT01490762
- Acronym / sponsor ID
- MKC-TI-176
- Conditions
- Healthy
- Keywords
- PK, PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Dec 2011 (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 is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
Detailed description
Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler:
- 10 U (one 10 U cartridge)
- 30 U (one 10 U and one 20 U cartridge)
- 60 U (three 20 U cartridges)
- 80 U (four 20 U cartridges)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Human Insulin | Active comparator | Drug: Regular Human InsulinSubcutaneous injection |
| TI and Regular Human Insulin | Experimental | Drug: Technosphere Insulin Inhalation Powder using the Gen2C inhalerAll subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- Good venous access for blood draws
- No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negative urine cotinine testing (< 100 ng/mL)
- Body mass index (BMI) < 32 kg/m2
- FEV1 = 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
Key exclusion criteria (19 listed)
- Blood donation of 500 mL within the previous 56 days
- Fasting blood sugar >130 mg/dL
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Allergy to study drug, food, or other study material (eg, peanuts, soy products)
- Clinically significant active or chronic illness
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 |
|---|---|---|
| Technosphere Insulin Inhalation Powder using the Gen2C inhalerInhalation Powder | Drug | TI and Regular Human Insulin |
| Regular Human InsulinSubcutaneous injection | Drug | Regular Human Insulin |
Primary outcome
area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
Time frame: crossover 4 times over the course of up to 5 weeks
3 secondary outcomes
Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)
Time frame: crossover 5 times over the course of up to 6 weeks
Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI
Time frame: crossover 5 times over the course of up to 6 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time frame: crossover 5 times for up to 6 weeks
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 7 Sep 2012.
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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.
Chief Medical Officer 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 Technosphere Insulin Inhalation Powder using the Gen2C inhaler and Regular Human Insulin in people with Healthy, 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 19 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 7 Sep 2012. 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?
area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing (time frame: crossover 4 times over the course of up to 5 weeks). 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 7 Sep 2012.