Back to resultsA First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
Primary Purpose
Diabetes Mellitus, Type 2, Healthy Males
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
MKC253 Inhalation Powder
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Healthy, Diabetes Mellitus: Type II
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Medical Centre Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
MKC253 Inhalation Powder
Outcomes
Primary Outcome Measures
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Secondary Outcome Measures
Incidence of pulmonary and other AEs
Pharmacokinetic (PK) parameters of plasma GLP-1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475371
Brief Title
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation
4. Oversight
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Healthy Males
Keywords
Healthy, Diabetes Mellitus: Type II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MKC253 Inhalation Powder
Intervention Type
Drug
Intervention Name(s)
MKC253 Inhalation Powder
Intervention Description
Inhalation powder
Primary Outcome Measure Information:
Title
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of pulmonary and other AEs
Time Frame
2 weeks
Title
Pharmacokinetic (PK) parameters of plasma GLP-1
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Baughman
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Centre Groningen
City
Zuidlaren
ZIP/Postal Code
9470 AE
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
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