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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014