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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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Treatment A
Single therapeutic dose of CHF 4226 pMDI
|
Drug: CHF 4226 pMDI
Inhaled solution, single therapeutic dose
Other Name: Carmoterol HFA
|
|
Experimental: Treatment B
Single supratherapeutic dose of CHF 4226 pMDI
|
Drug: CHF 4226 pMDI
Inhaled solution, single supratherapeutic dose
Other Name: Carmoterol HFA
|
|
Placebo Comparator: Treatment C
Single dose of placebo
|
Drug: Placebo
Inhaled solution, single dose of placebo
Other Name: Placebo
|
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Active Comparator: Treatment D
Single dose of moxifloxacin
|
Drug: Moxifloxacin
Tablet, oral, 400mg, single dose
Other Name: Avelox
|
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: | Steven E. Linberg, Ph.D., Chiesi Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00777595 History of Changes |
| Other Study ID Numbers: | CCD-0808-PR-0036 |
| Study First Received: | October 20, 2008 |
| Last Updated: | March 26, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
QTc CHF 4226 HFA pMDI Carmoterol |
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |