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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Healthy Males
• Interventions: Drug: MKC253 Inhalation Powder

• Registration Number: NCT00475371
• Lead Sponsor: Mannkind Corporation

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

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-17
• Study First Posted: 2007-05-21
• Primary Completion: 2007-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MKC253 Inhalation Powder	MKC253 Inhalation Powder

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder	2 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of pulmonary and other AEs	2 weeks
Pharmacokinetic (PK) parameters of plasma GLP-1	2 weeks

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Zuidlaren, Netherlands