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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Caucasians are defined as subjects with all four grandparents of European descent.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Dorval | Quebec | Canada |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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