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

MannKind

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Healthy Males

Treatments

Drug: MKC253 Inhalation Powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT00475371

MKC-253-001

EudraCT Number 2007-000361-37

Details and patient eligibility

About

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.

Full description

This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety & tolerability of MKC253 (GLP1/TechnosphereÂ®)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

Enrollment

26 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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