NCT00475371

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

May 16, 2007

Last Update Submit

June 12, 2012

Conditions

Diabetes Mellitus, Type 2Healthy Males

Keywords

HealthyDiabetes Mellitus: Type II

Outcome Measures

Primary Outcomes (1)

  • Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder

    2 weeks

Secondary Outcomes (2)

  • Incidence of pulmonary and other AEs

    2 weeks

  • Pharmacokinetic (PK) parameters of plasma GLP-1

    2 weeks

Study Arms (1)

1

EXPERIMENTAL

MKC253 Inhalation Powder

Drug: MKC253 Inhalation Powder

Interventions

MKC253 Inhalation PowderDRUG

Inhalation powder

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Zuidlaren, 9470 AE, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Robert Baughman

    Mannkind Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2007

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

NL(1)