Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: FTY720

Study type

Interventional

Funder types

Industry

Identifiers

CFTY720D2105

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.