Pharmacokinetic Study in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365117

Enrollment

Registered

2011-06-03

Start date

2011-01-31

Completion date

2011-04-30

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

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.

Interventions

DRUGTechnosphere® 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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered	0-120 minutes

Secondary

Measure	Time frame
Safety will be assessed by adverse events	32 days
Safety will be assessed by Spirometry (FEV1)	32 Days
Safety will be assessed by vital sign measurements	32 Days
Safety will be assessed by physical examination findings.	32 Days
Safety will be assessed by clinical laboratory test results.	32 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026