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Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416845
First Posted: December 28, 2006
Last Update Posted: June 4, 2010
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.
Information provided by:
Novartis
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


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.

Enrollment: 39
Study Start Date: October 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00416845     History of Changes
Other Study ID Numbers: CFTY720D2105
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: June 4, 2010
Last Verified: June 2010

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

Additional relevant MeSH terms:
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs