NCT01365117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1 month

First QC Date

June 1, 2011

Last Update Submit

June 12, 2012

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

    0-120 minutes

Secondary Outcomes (5)

  • 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

Study Arms (2)

Cohort 1

EXPERIMENTAL
Drug: Technosphere® Insulin Inhalation Powder

Cohort 2

EXPERIMENTAL
Drug: Technosphere® Insulin Inhalation Powder

Interventions

Technosphere® Insulin Inhalation PowderDRUG

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)

Also known as: Inhaled human insulin and Technosphere Powder
Cohort 1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Neptune City, New Jersey, 07753, United States

Location

Study Officials

  • Sandra Connolly, M.D.

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)