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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BAF 312
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • safety, tolerability, and pharmacokinetic profile
  • Maximum Tolerated Dose

Secondary Outcome Measures:
  • Lymphocyte counts and lymphocyte recovery period
  • Cardiac rate and rhythm
  • Pulmonary function

Estimated Enrollment: 63
Study Start Date: October 2006
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422175

Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422175     History of Changes
Other Study ID Numbers: CBAF312A2101
Study First Received: January 11, 2007
Last Updated: November 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Safety, tolerability, pharmacokinetics, pharmacodynamics, oral, BAF312, healthy volunteers

ClinicalTrials.gov processed this record on April 17, 2014