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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00422175
First received: January 11, 2007
Last updated: November 28, 2007
Last verified: November 2007

January 11, 2007
November 28, 2007
October 2006
Not Provided
  • safety, tolerability, and pharmacokinetic profile
  • Maximum Tolerated Dose
Same as current
Complete list of historical versions of study NCT00422175 on ClinicalTrials.gov Archive Site
  • Lymphocyte counts and lymphocyte recovery period
  • Cardiac rate and rhythm
  • Pulmonary function
Same as current
Not Provided
Not Provided
 
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
Drug: BAF 312
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
November 2007
Not Provided

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/exclusion criteria may apply.

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422175
CBAF312A2101
Not Provided
Not Provided
Novartis
Not Provided
Principal Investigator: Novartis Investigative site
Novartis
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP