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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2007-000361-37 |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MKC253 Inhalation Powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKC253 Inhalation Powder | Drug | Inhalation powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pulmonary and other AEs | 2 weeks | |
| Pharmacokinetic (PK) parameters of plasma GLP-1 | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Baughman | Mannkind Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Zuidlaren | 9470 AE | Netherlands |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |