Healthy VolunteersPhase 1NCT01982604
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
A Phase 1 study testing TI-Inhalation Powder A and TI-Inhalation Powder B in people with Healthy Volunteers, run by Mannkind Corporation at 1 site in United States.
Trial summary
A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TI-Inhalation Powder A and TI-Inhalation Powder B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- HNVs with a screening blood pressure less than 140/90 mm Hg
- Subjects who have hypertension controlled with up to 1 medication and who have a blood pressure less than 140/90 mm Hg
- Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional readings 5 minutes apart are allowed but the last blood pressure reading must be in range
- Subjects who have hypercholesterolemia controlled with up to 1 medication and who have a low-density lipoprotein value less than 160 mg/dL
- Good venous access for blood draws
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- No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL
- Body mass index (BMI) < 32 kg/m2
- Completion of informed consent form
Who cannot join
- Blood donation (500 mL) within the last 8 weeks
- Fasting blood sugar >100 mg/dL
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Allergy to study drug, components of Boost and Boost Plus, or other study material
- Clinically significant active or chronic illness
- History of asthma, COPD, or any other clinically relevant chronic lung disease
Show all 16Show fewer
- Respiratory tract infection within 4 weeks before screening
- History of drug or alcohol abuse within the past 5 years
- Positive urine drug screen
- Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
- 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
- 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
- Women of childbearing potential (premenopausal who have not undergone hysterectomy or bilateral tubal ligation, 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.
- Any subject who, in the opinion of the PI or a designee, appears not to be qualified for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers
A Phase 1, open-label randomized crossover trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.
- Conditions
- Healthy Volunteers
- Being tested
- TI-Inhalation Powder A, TI-Inhalation Powder B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-Inhalation Powder ADrug
Inhaled Insulin
TI-Inhalation Powder BDrug
Inhaled Insulin
| Study group | Role | What they receive |
|---|---|---|
| Sequence (Group) 1 | Experimental | Subjects randomized to Sequence 1 will receive TI in the following sequence:
TI-Inhalation Powder A TI-Inhalation Powder B
*30 units (10 units + 20 units) Receives: Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B |
| Sequence (Group) 2 | Experimental | Subjects randomized to Sequence 2 will receive TI in the following sequence:
TI-Inhalation Powder B TI-Inhalation Powder A
*30 units (10 units + 20 units) Receives: Drug: TI-Inhalation Powder A; Drug: TI-Inhalation Powder B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
Measured: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Cmax (maximum serum insulin concentration)
Measured: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Secondary outcomes (1)
GIR (area-under-the-serum Glucose Infusion Rate)
Measured: 0 to 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- 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
- 38 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
- NCT01982604
- Sponsor's protocol ID
- MKC-TI-179
- Status last verified
- Oct 2014
- First submitted
- 6 Nov 2013
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 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 to Evaluate PK/PD of 30 U TI Inhalation Powders Prepared With Insulin From Two Different Suppliers
- ClinicalTrials.gov ID
- NCT01982604
- Acronym / sponsor ID
- MKC-TI-179
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Nov 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 trial in Healthy Volunteers to evaluate the PK/PD of TI (Technosphere® Insulin) prepared with insulin from two different suppliers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence (Group) 1 | Experimental | Drug: TI-Inhalation Powder A, Drug: TI-Inhalation Powder BSubjects randomized to Sequence 1 will receive TI in the following sequence: TI-Inhalation Powder A TI-Inhalation Powder B *30 units (10 units + 20 units) |
| Sequence (Group) 2 | Experimental | Drug: TI-Inhalation Powder A, Drug: TI-Inhalation Powder BSubjects randomized to Sequence 2 will receive TI in the following sequence: TI-Inhalation Powder B TI-Inhalation Powder A *30 units (10 units + 20 units) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women aged 18 to 55 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- Good venous access for blood draws
- No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine cotinine testing < 100 ng/mL
- Body mass index (BMI) < 32 kg/m2
- Completion of informed consent form
Key exclusion criteria (16 listed)
- Blood donation (500 mL) within the last 8 weeks
- Fasting blood sugar >100 mg/dL
- History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- Allergy to study drug, components of Boost and Boost Plus, or other study material
- 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 |
|---|---|---|
| TI-Inhalation Powder AInhaled Insulin | Drug | Sequence (Group) 1, Sequence (Group) 2 |
| TI-Inhalation Powder BInhaled Insulin | Drug | Sequence (Group) 1, Sequence (Group) 2 |
Primary outcome
AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes
Time frame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
Cmax (maximum serum insulin concentration)
Time frame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240
1 secondary outcome
GIR (area-under-the-serum Glucose Infusion Rate)
Time frame: 0 to 360
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 2 Oct 2014.
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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.
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 TI-Inhalation Powder A and TI-Inhalation Powder B 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 9 inclusion and 16 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 2 Oct 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?
AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutes (time frame: 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210, 240). 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 2 Oct 2014.