Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: FTY720

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: December 27, 2006
• First Submitted That Met QC Criteria: December 27, 2006
• First Posted (Estimate): December 28, 2006

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Healthy male and female subjects; pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2105