Healthy VolunteersPhase 1NCT01365117
Pharmacokinetic Study in Healthy Volunteers
A Phase 1 study testing Technosphere® Insulin Inhalation Powder in people with Healthy Volunteers, run by Mannkind Corporation at 1 site in United States.
Trial summary
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Technosphere® Insulin Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2011
- 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
- Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
- Body mass index (BMI) < 32 kg/m2
- FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
Who cannot join
- Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Blood donation within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
Read the detailed description
Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.
- Conditions
- Healthy Volunteers
- Being tested
- Technosphere® Insulin Inhalation Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere® Insulin Inhalation PowderDrug
Also called Inhaled human insulin and Technosphere Powder
15 subjects in a three-way crossover (three different doses of TI Inhalation Powder [one 20 U, two 20 U and one 40 U cartridges)
Technosphere® Insulin Inhalation PowderDrug
Also called Inhaled human insulin and Technosphere Powder
16 subjects in a four-way crossover (four different doses of TI Inhalation Powder [one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)])
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Technosphere® Insulin Inhalation Powder |
| Cohort 2 | Experimental | Not described Receives: Drug: Technosphere® Insulin Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
Measured: 0-120 minutes
Secondary outcomes (5)
Safety will be assessed by adverse events
Measured: 32 days
Safety will be assessed by Spirometry (FEV1)
Measured: 32 Days
Safety will be assessed by vital sign measurements
Measured: 32 Days
Safety will be assessed by physical examination findings.
Measured: 32 Days
Safety will be assessed by clinical laboratory test results.
Measured: 32 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Connolly, M.D., Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365117
- Sponsor's protocol ID
- MKC-TI-167
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2011
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler
- ClinicalTrials.gov ID
- NCT01365117
- Acronym / sponsor ID
- MKC-TI-167
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Jun 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.
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
Detailed description
Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Technosphere® Insulin Inhalation Powder |
| Cohort 2 | Experimental | Drug: Technosphere® Insulin Inhalation Powder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
- Body mass index (BMI) < 32 kg/m2
- FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
Key exclusion criteria (3 listed)
- Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Blood donation within the previous 3 months
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 PowderAlso: Inhaled human insulin and Technosphere Powder15 subjects in a three-way crossover (three different doses of TI Inhalation Powder [one 20 U, two 20 U and one 40 U cartridges) | Drug | Cohort 1 |
| Technosphere® Insulin Inhalation PowderAlso: Inhaled human insulin and Technosphere Powder16 subjects in a four-way crossover (four different doses of TI Inhalation Powder [one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)]) | Drug | Cohort 2 |
Primary outcome
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
Time frame: 0-120 minutes
5 secondary outcomes
Safety will be assessed by adverse events
Time frame: 32 days
Safety will be assessed by Spirometry (FEV1)
Time frame: 32 Days
Safety will be assessed by vital sign measurements
Time frame: 32 Days
Safety will be assessed by physical examination findings.
Time frame: 32 Days
Safety will be assessed by clinical laboratory test results.
Time frame: 32 Days
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 14 Jun 2012.
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Screening Protocol
Pain
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.
Sandra Connolly, M.D. principal investigator
Celerion
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 in people with Healthy Volunteers, 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 3 inclusion and 3 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 14 Jun 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?
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered (time frame: 0-120 minutes). 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 14 Jun 2012.