Healthy
Conditions
Keywords
Safety, tolerability, pharmacokinetics, pharmacodynamics, oral, BAF312, healthy volunteers
Brief 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
Interventions
DRUGBAF 312
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability, and pharmacokinetic profile | — |
| Maximum Tolerated Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte counts and lymphocyte recovery period | — |
| Cardiac rate and rhythm | — |
| Pulmonary function | — |
Countries
United States
Outcome results
None listed