Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

• Sponsor: Mannkind Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01902121
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Technosphere® Insulin 10U + 20U; Drug: Technosphere® Insulin 30U	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TI 30 units (10 unit + 20 unit Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge	Drug: Technosphere® Insulin 10U + 20U; Inhaled Insulin
Experimental: TI 30 units (30 unit cartridge Technosphere® Insulin 30 units given as one 30 unit cartridge	Drug: Technosphere® Insulin 30U; Inhaled Insulin

Outcome Measures

Primary Outcome Measures

1. Area-under-the-serum insulin concentration versus time curve (AUC0-240min [0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis

• No smoking in the past 6 months (including cigarettes, cigars, and pipes)

• Urine cotinine testing < 100 ng/mL

• Body mass index < 32 kg/m2

• Completion of informed consent form

Exclusion Criteria:

• FBG > 100 mg/dL

• Clinically significant active or chronic illness

• History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease

• Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit

• Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Neptune	New Jersey	United States	07753

Sponsors and Collaborators

• Mannkind Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mannkind Corporation
• ClinicalTrials.gov Identifier: NCT01902121
• Other Study ID Numbers: MKC-TI-178
• First Posted: Jul 18, 2013
• Last Update Posted: Dec 12, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Dec 12, 2014