Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00422175
• Lead Sponsor: Novartis

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Status Verified: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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/exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose

Secondary Outcome Measures

Name	Time	Method
Pulmonary function
Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States