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| Sponsor: | Chiesi Farmaceutici S.p.A. |
|---|---|
| Collaborator: |
Chiesi Pharmaceuticals Inc. |
| Information provided by: | Chiesi Farmaceutici S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00777595 |
Purpose
The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: CHF 4226 pMDI Drug: Placebo Drug: Moxifloxacin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study |
| Official Title: | A Randomized, Double Blind, Single Dose, Positive and Placebo Controlled, Crossover Study of the Effects of Inhaled Carmoterol, at the Proposed Therapeutic and Supratherapeutic Doses, on the QTc Intervals in Healthy Subjects |
| Enrollment: | 47 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment A: Experimental
Single therapeutic dose of CHF 4226 pMDI
|
Drug: CHF 4226 pMDI
Inhaled solution, single therapeutic dose
|
|
Treatment B: Experimental
Single supratherapeutic dose of CHF 4226 pMDI
|
Drug: CHF 4226 pMDI
Inhaled solution, single supratherapeutic dose
|
|
Treatment C: Placebo Comparator
Single dose of placebo
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Drug: Placebo
Inhaled solution, single dose of placebo
|
|
Treatment D: Active Comparator
Single dose of moxifloxacin
|
Drug: Moxifloxacin
Tablet, oral, 400mg, single dose
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The secondary purposes of this study are to 1) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of carmoterol; 2) expand the available information on plasma pharmacokinetics and urine excretion for inhaled carmoterol at the proposed therapeutic and supra-therapeutic doses; and 3) generate additional safety information.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | Robert I. Cooper, MD | PRACS Institute, Ltd. |
| Study Director: | Steven E. Linberg, PhD | Chiesi Pharmaceuticals Inc. |
More Information
| Responsible Party: | Chiesi Pharmaceuticals Inc. ( Steven E. Linberg, Ph.D. ) |
| Study ID Numbers: | CCD-0808-PR-0036 |
| Study First Received: | October 20, 2008 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00777595 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
QTc CHF 4226 HFA pMDI Carmoterol |
|
Anti-Infective Agents Lung Diseases, Obstructive Respiratory Tract Diseases Moxifloxacin |
Therapeutic Uses Lung Diseases Pharmacologic Actions Pulmonary Disease, Chronic Obstructive |