Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers (CT14)
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ClinicalTrials.gov Identifier: NCT00777595 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : March 27, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: CHF 4226 pMDI Drug: Placebo Drug: Moxifloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
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 |
Active Comparator: Treatment D
Single dose of moxifloxacin
|
Drug: Moxifloxacin
Tablet, oral, 400mg, single dose
Other Name: Avelox |
- QTci [ Time Frame: ECGs taken every treatment period on day -1 and day +1 at -1, -0.5, -0.25, 0.08, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs ]
- QTcX interval (subject-specific correction of QTcF, QTcB and QTcH) [ Time Frame: ECGs taken every treatment period on day -1 and day +1 at -1, -0.5, -0.25, 0.08, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs ]
- Plasma concentration (AUC, Cmax, Tmax) [ Time Frame: Each treatment period on dosing day at -0.75, 0.08, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs ]
- Urinary excretion (Ae) [ Time Frame: Each treatment period on day of dosing at -0.75, 0.58 and 24 hours. ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult male or female subjects, 18-55 years of age who provided written informed consent.
- A body mass index (BMI) between 18 - 30, inclusive.
- A normal blood pressure (< 140mmHg systolic and < 90mmHg diastolic)
- A normal 12-lead ECG (QTcF interval < 450msec for males and < 470msec for females).
- A serum potassium </= 4.0mEq/L.
- A calculated creatinine clearance > 80mL/min.
- Male subjects must agree to use a medically acceptable contraceptive (abstain from sexual intercourse, or use a condom with spermicide), have had a vasectomy at least 6 months prior to study participation or have a partner who is not of childbearing potential.
Exclusion Criteria:
- A history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- A history of sensitivity or allergy to the quinolone class of antibiotics and/or a beta 2 adrenergic receptor agonist.
- Clinically significant screening results (laboratory profiles, medical histories, ECGs, physical exam).
- Hemoglobin below the normal reference range for the testing laboratory.
- Abuse of alcohol or other substances.
- Current use of tobacco products.
- Subjects with a positive laboratory test result for hepatitis B, hepatitis C, HIV, controlled substances, cotinine or alcohol.
- Any prescription medication taken within 14 days (or 5 elimination half-lives, whichever is longer) of Study Day -2, or have taken any over-the-counter medications, including topical medications, vitamins, herbal or dietary supplements/remedies (e.g., Saint John's Wort or Milk Thistle), within 14 days of Study Day -2, or planned concomitant medication while in the study (except for acetaminophen up to 2g/day), with the exception of hormonal birth control medications or hormone replacement therapy for females.
- A history of additional risk factors for Torsade de Pointes (e.g., hypokalemia, history of drowning survival, family history of Long QT Syndrome, family history of Short QT Syndrome, or family history of unexplainable early sudden death).
- Subject is pregnant or lactating female, or female at risk of pregnancy (i.e., not using an adequate contraceptive method: surgical sterilization [e.g., bilateral tubal ligation], hormonal contraception [implantable, patch, oral], IUD, and double-barrier methods [any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical dap]_.
- Participation in a study of an investigational drug within 30 days prior to the baseline ECG.
- Any condition that, in the judgment of the Investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777595
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 Farmaceutici S.p.A. |
Responsible Party: | Steven E. Linberg, Ph.D., Chiesi Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00777595 |
Other Study ID Numbers: |
CCD-0808-PR-0036 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | March 27, 2009 |
Last Verified: | March 2009 |
QTc CHF 4226 HFA pMDI Carmoterol |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Moxifloxacin Anti-Bacterial Agents |
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