Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 27, 2006
Last updated: June 3, 2010
Last verified: June 2010

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
Drug: FTY720
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

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

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

United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080
Sponsors and Collaborators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00416845     History of Changes
Other Study ID Numbers: CFTY720D2105
Study First Received: December 27, 2006
Last Updated: June 3, 2010
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

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

ClinicalTrials.gov processed this record on April 17, 2014