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

NCT ID: NCT00475371

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30

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

Conditions

Diabetes Mellitus, Type 2; Healthy Males

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

MKC253 Inhalation Powder

Group Type: EXPERIMENTAL

MKC253 Inhalation Powder

Intervention Type: DRUG

Inhalation powder

Interventions

MKC253 Inhalation Powder

Inhalation powder

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mannkind Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Baughman

Role: STUDY_DIRECTOR

Mannkind Corporation

Locations

University Medical Centre Groningen

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

EudraCT Number 2007-000361-37

Identifier Type: -

Identifier Source: secondary_id

MKC-253-001

Identifier Type: -

Identifier Source: org_study_id