Status:
COMPLETED
Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00416845
Start Date
October 1 2006
Last Update
June 4 2010
Active Locations (1)
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1
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080