HealthyPhase 1NCT00416546
Safety of AEB071 in Healthy Volunteers and to Compare the Ethnicity, Metabolic, and Safety Effects Between Caucasian and Japanese Healthy Subjects
A Phase 1 study testing AEB071 in people with Healthy, run by Novartis at 1 site in Canada.
Trial summary
This is a study to assess the safety effects after multiple doses of AEB071 in healthy volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and Japanese healthy subjects receiving single and multiple doses of AEB071. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AEB071
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male or female subjects having provided written, informed, consent before entering the study. Light smokers (≤10 cigarettes/day) will be eligible for inclusion in this study. Smokers will be defined as any subject who reports cigarette use or has a urine cotinine greater than 500 ng/mL.
- Female subjects must be either surgically sterilized at least 6 months or practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom).
- Subjects must have a body weight between 45 and 90 kg and a body mass index (BMI) between 18-28 kg/m2.
- Japanese subjects of 1st, 2nd, or 3rd generation ethnic origin or Caucasian.
- Japanese subjects will be defined as being of Japanese ethnicity with all 4 grandparents of Japanese descent. Generations will be defined as follows:
- 'First generation' Japanese are subjects who were born in Japan to parents of Japanese ethnicity.
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- 'Second generation' will be defined as subjects who were born outside of Japan to 1st generation Japanese parents.
- 'Third generation' will be defined as subjects born outside of Japan to 2nd generation Japanese parents, i.e. 4 grandparents from Japan but both parents and subject born elsewhere.
- Caucasians are defined as subjects with all four grandparents of European descent.
Who cannot join
- Presence and/or history of a clinically significant illness within two weeks prior to dosing, history of drug or alcohol abuse within the 12 months prior to dosing, use of any prescription drug or over-the-counter (OTC) medication (acetaminophen is acceptable) within 14 days prior to dosing.
- Presence of a clinically significant systemic illness, active infectious process (viral or bacterial), e.g., cold sore, or documented drug allergies that may deteriorate or affect the subject's safety or ability to cooperate during the study.
- Laboratory or clinical evidence suggestive of liver or renal disease, history of heart disease, history of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia), history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), history of major gastrointestinal disease, history or clinical evidence of pancreatic injury or pancreatitis
- Subjects with a resting heart rate < 50 beats per minute (bpm)
- Subjects with systolic blood pressure < 90 or diastolic blood pressure < 50.
- Subjects with lymphocyte counts less than 1200/mm3 or total white blood cell (WBC) greater than 10000/mm3 at baseline
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- A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
- Subjects who intend to or have received any live attenuated vaccines 4 weeks prior to or during the study period.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled Study of AEB071 in Healthy Volunteers to Evaluate the Safety/Tolerability of 14 Day Multiple-Dose AEB071 and Measure the Effect of Ethnicity on Pharmacokinetics, Pharmacodynamics and Safety/Tolerability in Caucasian and Japanese Subjects Receiving Single and Multiple Doses of AEB071
This is a study to assess the safety effects after multiple doses of AEB071 in healthy volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and Japanese healthy subjects receiving single and multiple doses of AEB071.
- Conditions
- Healthy
- Being tested
- AEB071
- Keywords
- Healthy Caucasians, Healthy Japanese subjects, Immunosuppressant, early T-cell activation blockers, inhibition of protein kinase C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pharmacokinetics between healthy Caucasian and Japanese subjects after a single oral dose of AEB071
To compare the pharmacokinetics between healthy Caucasian and Japanese subjects after 7 days of oral, daily doses of AEB071
To compare the safety and tolerability of single and multiple oral doses of AEB071 in healthy Japanese and Caucasian subjects
Secondary outcomes (1)
To compare the dose response, temporal course and effect of AEB071 on lymphocyte proliferation after single oral doses of AEB071 in healthy Caucasian and Japanese subjects
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
- Study completionOct 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416546
- Sponsor's protocol ID
- CAEB071A2113
- Status last verified
- Jan 2008
- First submitted
- 27 Dec 2006
- Last updated
- 11 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled Study of AEB071 in Healthy Volunteers to Evaluate the Safety/Tolerability of 14 Day Multiple-Dose AEB071 and Measure the Effect of Ethnicity on Pharmacokinetics, Pharmacodynamics and Safety/Tolerability in Caucasian and Japanese Subjects Receiving Single and Multiple Doses of AEB071
- ClinicalTrials.gov ID
- NCT00416546
- Acronym / sponsor ID
- CAEB071A2113
- Conditions
- Healthy
- Keywords
- Healthy Caucasians, Healthy Japanese subjects, Immunosuppressant, early T-cell activation blockers, inhibition of protein kinase C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Oct 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 is a study to assess the safety effects after multiple doses of AEB071 in healthy volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and Japanese healthy subjects receiving single and multiple doses of AEB071.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy, male or female subjects having provided written, informed, consent before entering the study. Light smokers (≤10 cigarettes/day) will be eligible for inclusion in this study. Smokers will be defined as any subject who reports cigarette use or has a urine cotinine greater than 500 ng/mL.
- Female subjects must be either surgically sterilized at least 6 months or practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom).
- Subjects must have a body weight between 45 and 90 kg and a body mass index (BMI) between 18-28 kg/m2.
- Japanese subjects of 1st, 2nd, or 3rd generation ethnic origin or Caucasian.
- Japanese subjects will be defined as being of Japanese ethnicity with all 4 grandparents of Japanese descent. Generations will be defined as follows:
Key exclusion criteria (9 listed)
- Presence and/or history of a clinically significant illness within two weeks prior to dosing, history of drug or alcohol abuse within the 12 months prior to dosing, use of any prescription drug or over-the-counter (OTC) medication (acetaminophen is acceptable) within 14 days prior to dosing.
- Presence of a clinically significant systemic illness, active infectious process (viral or bacterial), e.g., cold sore, or documented drug allergies that may deteriorate or affect the subject's safety or ability to cooperate during the study.
- Laboratory or clinical evidence suggestive of liver or renal disease, history of heart disease, history of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia), history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), history of major gastrointestinal disease, history or clinical evidence of pancreatic injury or pancreatitis
- Subjects with a resting heart rate < 50 beats per minute (bpm)
- Subjects with systolic blood pressure < 90 or diastolic blood pressure < 50.
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 |
|---|---|---|
| AEB071 | Drug | – |
Primary outcome
To compare the pharmacokinetics between healthy Caucasian and Japanese subjects after a single oral dose of AEB071
To compare the pharmacokinetics between healthy Caucasian and Japanese subjects after 7 days of oral, daily doses of AEB071
To compare the safety and tolerability of single and multiple oral doses of AEB071 in healthy Japanese and Caucasian subjects
1 secondary outcome
To compare the dose response, temporal course and effect of AEB071 on lymphocyte proliferation after single oral doses of AEB071 in healthy Caucasian and Japanese subjects
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 11 Aug 2008.
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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
Novartis
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 AEB071 in people with Healthy, run by Novartis at 1 site in Canada.
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 9 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 11 Aug 2008. 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 Canada. 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?
To compare the pharmacokinetics between healthy Caucasian and Japanese subjects after a single oral dose of AEB071. The study lists 3 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 11 Aug 2008.