HealthyPhase 1NCT00422175
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
A Phase 1 study testing BAF 312 in people with Healthy, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BAF 312
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, 18 to 55 years of age included, and in good health
- Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years)
- Female subjects test are required to have a negative result for a pregnancy test, not be lactating/breast feeding, and must either:
- Body mass index (BMI) must be within the range of 18 to 30 Kg/m2. Subjects must weigh at least 50 kg to participate in this study.
- Able to communicate with the investigator, to understand and comply with the requirements of the study
- Understand and sign the written informed consent firm
Who cannot join
- Smokers
- Subjects who received live vaccine 4 weeks prior to dosing.
- Use of any prescription drugs four weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two weeks prior to dosing. Acetaminophen is acceptable
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- Significant illness within two weeks prior to dosing.
Show all 9Show fewer
- A past personal or close family medical history of clinically significant cardiac abnormalities
- History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse
- Additional protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human Study for BAF312: A Two Parts, Single Center, Randomized, Double-Blind, Placebo-Controlled Ascending Single Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral BAF312 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers
- Conditions
- Healthy
- Being tested
- BAF 312
- Keywords
- Safety, tolerability, pharmacokinetics, pharmacodynamics, oral, BAF312, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAF 312Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose
Secondary outcomes (3)
Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm
Pulmonary function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startOct 2006
- Study completionNov 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
- 63 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422175
- Sponsor's protocol ID
- CBAF312A2101
- Status last verified
- Nov 2007
- First submitted
- 11 Jan 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study for BAF312: A Two Parts, Single Center, Randomized, Double-Blind, Placebo-Controlled Ascending Single Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral BAF312 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00422175
- Acronym / sponsor ID
- CBAF312A2101
- Conditions
- Healthy
- Keywords
- Safety, tolerability, pharmacokinetics, pharmacodynamics, oral, BAF312, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Jan 2007 (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.
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects, 18 to 55 years of age included, and in good health
- Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years)
- Female subjects test are required to have a negative result for a pregnancy test, not be lactating/breast feeding, and must either:
- Body mass index (BMI) must be within the range of 18 to 30 Kg/m2. Subjects must weigh at least 50 kg to participate in this study.
- Able to communicate with the investigator, to understand and comply with the requirements of the study
Key exclusion criteria (9 listed)
- Smokers
- Subjects who received live vaccine 4 weeks prior to dosing.
- Use of any prescription drugs four weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two weeks prior to dosing. Acetaminophen is acceptable
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
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 |
|---|---|---|
| BAF 312 | Drug | – |
Primary outcome
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose
3 secondary outcomes
Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm
Pulmonary function
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 29 Nov 2007.
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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
Investigative 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 BAF 312 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 6 inclusion and 9 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 29 Nov 2007. 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?
safety, tolerability, and pharmacokinetic profile. The study lists 2 primary outcomes in all. 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 29 Nov 2007.