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OpenTrials
Completed

NCT Number: NCT00475371

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Males Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Centre Groningen

Zuidlaren, 9470 AE, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MKC253 Inhalation Powder

Drug

Inhalation powder

Primary outcomes

  1. Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder

    Time frame: 2 weeks

Secondary outcomes

  1. Incidence of pulmonary and other AEs

    Time frame: 2 weeks

  2. Pharmacokinetic (PK) parameters of plasma GLP-1

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study title

A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects

Important dates

Study start
2007
Primary completion
2007
First posted
May 21, 2007
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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