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A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males

Sponsor
Mannkind Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00475371
Collaborator
(none)
26
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MKC253 Inhalation Powder
 Phase 1

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

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

MKC253 Inhalation Powder

Drug: MKC253 Inhalation Powder
Inhalation powder

Outcome Measures

Primary Outcome Measures

  1. Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder [2 weeks]

Secondary Outcome Measures

  1. Incidence of pulmonary and other AEs [2 weeks]

  2. Pharmacokinetic (PK) parameters of plasma GLP-1 [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Centre Groningen Zuidlaren Netherlands 9470 AE

Sponsors and Collaborators

  • Mannkind Corporation

Investigators

  • Study Director: Robert Baughman, Mannkind Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00475371
Other Study ID Numbers:
  • MKC-253-001
  • EudraCT Number 2007-000361-37
First Posted:
May 21, 2007
Last Update Posted:
Jun 14, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Mannkind Corporation
Healthy
Diabetes Mellitus: Type II
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 14, 2012