Diabetes Mellitus, Type 2Phase 1NCT00475371
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
A Phase 1 study testing MKC253 Inhalation Powder in people with Diabetes Mellitus, Type 2 and Healthy Males, run by Mannkind Corporation at 1 site in Netherlands.
Trial summary
26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit. Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Healthy Males
- What is being tested?
- MKC253 Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Jun 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males = 18 and = 45 years of age
- Written Informed Consent.
- Body Mass Index (BMI) of < 30 kg/m2
- Non-smoker
- Normal pulmonary function and performance on pulmonary function tests
Who cannot join
- Clinically significant disease including diabetes mellitus
- Fasting blood glucose > 110 mg/dL (6.1 mmol/L)
- Significant psychiatric condition or drug or alcohol abuse
- Any other condition which, 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
- Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit.
Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.
Read the detailed description
This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety \& tolerability of MKC253 (GLP1/Technosphere®)Inhalation Powder.
The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 \& 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data
- Conditions
- Diabetes Mellitus, Type 2, Healthy Males
- Being tested
- MKC253 Inhalation Powder
- Keywords
- Healthy, Diabetes Mellitus: Type II
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKC253 Inhalation PowderDrug
Inhalation powder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MKC253 Inhalation Powder Receives: Drug: MKC253 Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Measured: 2 weeks
Secondary outcomes (2)
Incidence of pulmonary and other AEs
Measured: 2 weeks
Pharmacokinetic (PK) parameters of plasma GLP-1
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Baughman, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475371
- Sponsor's protocol ID
- MKC-253-001
- Other IDs
- EudraCT Number 2007-000361-37
- Status last verified
- Jun 2012
- First submitted
- 16 May 2007
- Last updated
- 14 Jun 2012
- Results posted
- 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
- A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT00475371
- Acronym / sponsor ID
- MKC-253-001
- Conditions
- Diabetes Mellitus, Type 2, Healthy Males
- Keywords
- Healthy, Diabetes Mellitus: Type II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jun 2007 (actual)
- First posted
- 21 May 2007 (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.
26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit.
Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.
Detailed description
This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety \& tolerability of MKC253 (GLP1/Technosphere®)Inhalation Powder.
The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 \& 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MKC253 Inhalation PowderMKC253 Inhalation Powder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males = 18 and = 45 years of age
- Written Informed Consent.
- Body Mass Index (BMI) of < 30 kg/m2
- Non-smoker
- Normal pulmonary function and performance on pulmonary function tests
Key exclusion criteria (5 listed)
- Clinically significant disease including diabetes mellitus
- Fasting blood glucose > 110 mg/dL (6.1 mmol/L)
- Significant psychiatric condition or drug or alcohol abuse
- Any other condition which, 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
- Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
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 |
|---|---|---|
| MKC253 Inhalation PowderInhalation powder | Drug | 1 |
Primary outcome
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Time frame: 2 weeks
2 secondary outcomes
Incidence of pulmonary and other AEs
Time frame: 2 weeks
Pharmacokinetic (PK) parameters of plasma GLP-1
Time frame: 2 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 14 Jun 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.
Robert Baughman study director
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 MKC253 Inhalation Powder in people with Diabetes Mellitus, Type 2 and Healthy Males, run by Mannkind Corporation at 1 site in Netherlands.
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 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 Netherlands. 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?
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder (time frame: 2 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 14 Jun 2012.