Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

NCT00416845 | Completed Phase 1

• 1 other identifier: CFTY720D2105
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator; Healthy male and female subjects

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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.

Interventions

FTY720 DRUG

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking,(ie. 6 months w/o the use of nicotine or nicotine containing products), male or female subjects.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

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

Location

MeSH Terms

Interventions

Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2007
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

US (1)