Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

NCT ID: NCT00416845

Last Updated: 2010-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

FTY720

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CFTY720D2105

Identifier Type: -

Identifier Source: org_study_id