Pharmacokinetic Study in Healthy Volunteers | NCT01365117

Studies
Pharmacokinetic Study in Healthy Volunteers

NCT01365117

Sponsor

Mannkind Corporation

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

50Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Technosphere® Insulin Inhalation Powder
Technosphere® Insulin Inhalation Powder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Feb 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental		Drug: Technosphere® Insulin Inhalation Powder
Cohort 2	Experimental		Drug: Technosphere® Insulin Inhalation Powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)](streamdown:incomplete-link)	Cohort 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Connolly, M.D.	Celerion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Neptune City	New Jersey	07753	United States