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Pharmacokinetic Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01365117
First received: June 1, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.


Condition Intervention Phase
Healthy Volunteers
 Drug: Technosphere® Insulin Inhalation Powder
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety will be assessed by adverse events [ Time Frame: 32 days ] [ Designated as safety issue: Yes ]
  • Safety will be assessed by Spirometry (FEV1) [ Time Frame: 32 Days ] [ Designated as safety issue: Yes ]
  • Safety will be assessed by vital sign measurements [ Time Frame: 32 Days ] [ Designated as safety issue: Yes ]
  • Safety will be assessed by physical examination findings. [ Time Frame: 32 Days ] [ Designated as safety issue: Yes ]
  • Safety will be assessed by clinical laboratory test results. [ Time Frame: 32 Days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: Technosphere® Insulin Inhalation Powder
15 subjects in a three-way crossover (three different doses of TI Inhalation Powder [one 20 U, two 20 U and one 40 U cartridges)
Other Name: Inhaled human insulin and Technosphere Powder
Experimental: Cohort 2 Drug: Technosphere® Insulin Inhalation Powder
16 subjects in a four-way crossover (four different doses of TI Inhalation Powder [one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)])
Other Name: Inhaled human insulin and Technosphere Powder

Detailed Description:

Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
  • Body mass index (BMI) < 32 kg/m2
  • FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

  • Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
  • History of coronary artery disease, peripheral vascular disease, or congestive heart failure
  • Blood donation within the previous 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365117

Locations
United States, New Jersey
Celerion
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Mannkind Corporation
Investigators
Principal Investigator: Sandra Connolly, M.D. Celerion
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01365117     History of Changes
Other Study ID Numbers: MKC-TI-167
Study First Received: June 1, 2011
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013