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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475371
• Other study ID #: MKC-253-001
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2007
• Last updated: June 12, 2012
• Start date: April 2007

Study information

• Verified date: June 2012
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy Males

Intervention

Drug:
• MKC253 Inhalation Powder
Inhalation powder

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder		2 weeks	Yes
Secondary	Incidence of pulmonary and other AEs		2 weeks	Yes
Secondary	Pharmacokinetic (PK) parameters of plasma GLP-1		2 weeks	No