HealthyPhase 1NCT00416845
Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers
A Phase 1 study testing FTY720 in people with Healthy, run by Novartis at 1 site in United States.
Trial summary
This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FTY720
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- FTY720
- Keywords
- pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator, Healthy male and female subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTY720Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416845
- Sponsor's protocol ID
- CFTY720D2105
- Status last verified
- Jun 2010
- First submitted
- 27 Dec 2006
- Last updated
- 4 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00416845
- Acronym / sponsor ID
- CFTY720D2105
- Conditions
- Healthy
- Keywords
- pharmacodynamic effects, cardiac effects, healthy subjects, synthetic sphingosine 1 phosphate (S1P) receptor modulator, Healthy male and female subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTY720 | Drug | – |
Primary outcome
Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FTY720 in people with Healthy, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of two doses of FTY720 on lung and cardiac (heart) functions in healthy volunteers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.