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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00721344 |
48 healthy adult male & female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible subjects will be randomized into a dosing regimen after admission.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: Technosphere Inhalation Powder (FDKP) Drug: Moxifloxacin Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
Official Title: | A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder in Healthy Subjects |
Estimated Enrollment: | 48 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 20mg
Drug: Moxifloxacin
Tablets 400mg
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 40mg
Drug: Placebo
Placebo cartridges
|
2: Experimental |
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 20mg
Drug: Moxifloxacin
Tablets 400mg
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 40mg
Drug: Placebo
Placebo cartridges
|
3: Experimental |
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 20mg
Drug: Moxifloxacin
Tablets 400mg
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 40mg
Drug: Placebo
Placebo cartridges
|
4: Experimental |
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 20mg
Drug: Moxifloxacin
Tablets 400mg
Drug: Technosphere Inhalation Powder (FDKP)
Technosphere® Inhalation Powder 40mg
Drug: Placebo
Placebo cartridges
|
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Charles River Clinical Services Northwest | Recruiting |
Tacoma, Washington, United States, 98418 | |
Contact: Robin Downey 253-593-5304 robin.downey@crl.com |
Responsible Party: | Charles River Cinical Services - Northwest Kinetics ( Robin L. Downey, MD ) |
Study ID Numbers: | MKC-T-131 |
Study First Received: | July 22, 2008 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00721344 |
Health Authority: | United States: Food and Drug Administration |
Healthy males and females |
Moxifloxacin Healthy |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |