Pharmacokinetic Study in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Technosphere® Insulin Inhalation Powder
- Registration Number
- NCT01365117
- Lead Sponsor
- Mannkind Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 2 Technosphere® Insulin Inhalation Powder - Cohort 1 Technosphere® Insulin Inhalation Powder -
- Primary Outcome Measures
Name Time Method The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered 0-120 minutes
- Secondary Outcome Measures
Name Time Method 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 clinical laboratory test results. 32 Days Safety will be assessed by physical examination findings. 32 Days
Trial Locations
- Locations (1)
Celerion
🇺🇸Neptune, New Jersey, United States