Healthy VolunteersPhase 1NCT01902121
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
A Phase 1 study testing Technosphere® Insulin 10U + 20U and Technosphere® Insulin 30U in people with Healthy Volunteers, run by Mannkind Corporation at 1 site in United States.
Trial summary
A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge. 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 10U + 20U and Technosphere® Insulin 30U
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- 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
- Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- No smoking in the past 6 months (including cigarettes, cigars, and pipes)
- Urine cotinine testing < 100 ng/mL
- Body mass index < 32 kg/m2
- Completion of informed consent form
Who cannot join
- FBG > 100 mg/dL
- Clinically significant active or chronic illness
- History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
- Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
- Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
- Conditions
- Healthy Volunteers
- Being tested
- Technosphere® Insulin 10U + 20U, Technosphere® Insulin 30U
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere® Insulin 10U + 20UDrug
Inhaled Insulin
Technosphere® Insulin 30UDrug
Inhaled Insulin
| Study group | Role | What they receive |
|---|---|---|
| TI 30 units (10 unit + 20 unit | Experimental | Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge Receives: Drug: Technosphere® Insulin 10U + 20U |
| TI 30 units (30 unit cartridge | Experimental | Technosphere® Insulin 30 units given as one 30 unit cartridge Receives: Drug: Technosphere® Insulin 30U |
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
Measured: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionAug 2014
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902121
- Sponsor's protocol ID
- MKC-TI-178
- Status last verified
- Dec 2014
- First submitted
- 15 Jul 2013
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
- ClinicalTrials.gov ID
- NCT01902121
- Acronym / sponsor ID
- MKC-TI-178
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jul 2013 (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.
A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TI 30 units (10 unit + 20 unit | Experimental | Drug: Technosphere® Insulin 10U + 20UTechnosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge |
| TI 30 units (30 unit cartridge | Experimental | Drug: Technosphere® Insulin 30UTechnosphere® Insulin 30 units given as one 30 unit cartridge |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- No smoking in the past 6 months (including cigarettes, cigars, and pipes)
- Urine cotinine testing < 100 ng/mL
- Body mass index < 32 kg/m2
- Completion of informed consent form
Key exclusion criteria (5 listed)
- FBG > 100 mg/dL
- Clinically significant active or chronic illness
- History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
- Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
- Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
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 10U + 20UInhaled Insulin | Drug | TI 30 units (10 unit + 20 unit |
| Technosphere® Insulin 30UInhaled Insulin | Drug | TI 30 units (30 unit cartridge |
Primary outcome
Area-under-the-serum insulin concentration versus time curve (AUC0-240min
Time frame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
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 12 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 10U + 20U and Technosphere® Insulin 30U 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 5 inclusion and 5 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 12 Dec 2014. 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 (time frame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing). 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 12 Dec 2014.