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Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

This study has been completed.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00416845
  Purpose

This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: FTY720
Phase I

Drug Information available for:   FTY 720    Fingolimod    S 1 (Combination)   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:   A Randomized, Parallel Group, Double-Blind, Placebo Controlled, 14 Days Multiple-Dose Treatment to Assess the Pulmonary and Cardiac Pharmacodynamics of FTY720 (0.5 and 1.25 mg) in Healthy Volunteers

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.

Secondary Outcome Measures:
  • Treatment initiation effect on heart rhythm.
  • Duration of dynamic effect on heart rate and rhythm.
  • Treatment initiation effect and duration of this effect on cardiac output and stroke volume.
  • Treatment initiation effect and the duration of this effect on pulmonary function with methacholine challenge.
  • Pharmacodynamic effect on absolute lymphocyte count.

Estimated Enrollment:   36
Study Start Date:   October 2006

  Eligibility
Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy, non-smoking,(ie. 6 months w/o the use of nicotine or nicotine containing products), male or female subjects.
  • Female subjects must be either surgically sterilized (including bilateral tubal ligation) at least 6 months or post-menopausal. Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion and menopause will be confirmed by a plasma FSH level of >40 IU/L.
  • Male subjects agree to refrain from sperm donation from check-in until 30 days beyond the conclusion of all study events.
  • Male subjects must agree to the use of condoms with spermicide with sexual intercourse from 14 days prior to check-in until 30 days beyond the last dose of study drug.
  • Resting heart rate ≥ 50 beats per minute (bpm)

Exclusion Criteria:

  • History or presence of any clinically significant events, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  • Subjects with systolic blood pressure < 90 mmHg or diastolic blood pressure < 50 mmHg
  • Male subjects with a QTcB > 450 msec
  • Female subjects with a QTcB > 470 msec
  • Subjects with pulmonary symptoms, history of exercise-induced asthma, asthma or chronic obstructive pulmonary disease (COPD)
  • Use of any prescription drug within 1 month of starting the study
  • Positive urine screen for alcohol or drugs at screening, unless the test is shown to be falsely positive on confirmation testing.
  • Hemoglobin < 12g/dL
  • Donation of blood or significant blood loss within 56 days prior to check in.
  • Donation of plasma within 7 days prior check in.
  • Participation in an investigational study within 30 days prior to check in.
  • Positive screening test for HIV or Hepatitis B or C.
  • A past history of cigarette smoking of > 10 pack-years or use of nicotine or nicotine-containing products 6 months prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416845

Locations
United States, New Jersey
Novartis Investigative Site    
      East Hanover, New Jersey, United States, 07936-1080

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis     Investigator site    
  More Information


Study ID Numbers:   CFTY720D2105
First Received:   December 27, 2006
Last Updated:   June 18, 2007
ClinicalTrials.gov Identifier:   NCT00416845
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novartis:
pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator  
Healthy male and female subjects  

Study placed in the following topic categories:
FTY 720
Healthy

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008




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