COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers (CT14)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00777595
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : March 27, 2009
Information provided by:
Chiesi Farmaceutici S.p.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: CHF 4226 pMDI Drug: Placebo Drug: Moxifloxacin Phase 1

Detailed Description:
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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Urinary excretion (Ae) [ Time Frame: Each treatment period on day of dosing at -0.75, 0.58 and 24 hours. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00777595

Layout table for location information
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Layout table for investigator information
Principal Investigator: Robert I. Cooper, MD PRACS Institute, Ltd.
Study Director: Steven E. Linberg, PhD Chiesi Farmaceutici S.p.A.
Layout table for additonal information
Responsible Party: Steven E. Linberg, Ph.D., Chiesi Pharmaceuticals Inc. 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
Keywords provided by Chiesi Farmaceutici S.p.A.:
CHF 4226 HFA
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents