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Completed

NCT Number: NCT01365117

Pharmacokinetic Study in Healthy Volunteers

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Neptune City, New Jersey, 07753, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Technosphere® Insulin Inhalation Powder

Drug

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 names: Inhaled human insulin and Technosphere Powder

Primary outcomes

  1. The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered

    Time frame: 0-120 minutes

Secondary outcomes

  1. Safety will be assessed by adverse events

    Time frame: 32 days

  2. Safety will be assessed by Spirometry (FEV1)

    Time frame: 32 Days

  3. Safety will be assessed by vital sign measurements

    Time frame: 32 Days

  4. Safety will be assessed by physical examination findings.

    Time frame: 32 Days

  5. Safety will be assessed by clinical laboratory test results.

    Time frame: 32 Days

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
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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