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Completed

NCT Number: NCT00416845

Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

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

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FTY720

Drug

Primary outcomes

  1. Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.

Secondary outcomes

  1. Treatment initiation effect on heart rhythm.

  2. Duration of dynamic effect on heart rate and rhythm.

  3. Treatment initiation effect and duration of this effect on cardiac output and stroke volume.

  4. Treatment initiation effect and the duration of this effect on pulmonary function with methacholine challenge.

  5. Pharmacodynamic effect on absolute lymphocyte count.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
First posted
Dec 28, 2006
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.