Effects of FTY720 on Heart and Lung Functions in Healthy... | NCT00416845

Studies
Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

NCT00416845

Sponsor

Novartis

Status

Completed

Last Update Posted

Jun 4, 2010Estimated

Enrollment

39Actual

Phase

Phase 1

Conditions

Healthy

Interventions

FTY720

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Not provided

First Submitted Date

Dec 27, 2006

First Submission Date that Met QC Criteria

Dec 27, 2006

First Posted Date

Dec 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2010

Last Update Posted Date

Jun 4, 2010Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Name	Type	Description	Arm Group Labels	Other Names
FTY720	Drug

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013110	Sphingosine
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Measure	Description	Time Frame
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.