Clinical trial NCT00416845: Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator
Healthy male and female subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-28
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.
Secondary outcomes:
measure: Treatment initiation effect on heart rhythm.
measure: Duration of dynamic effect on heart rate and rhythm.
measure: Treatment initiation effect and duration of this effect on cardiac output and stroke volume.
measure: Treatment initiation effect and the duration of this effect on pulmonary function with methacholine challenge.
measure: Pharmacodynamic effect on absolute lymphocyte count.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: