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

November 28, 2007 updated by: Novartis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose

Secondary Outcome Measures

Outcome Measure
Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm
Pulmonary function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBAF312A2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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