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Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416442
First Posted: December 28, 2006
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.

Condition Intervention Phase
Healthy Drug: RSV604 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Single- to Multiple-dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of RSV604 Intravenous Formulation in Healthy Subjects

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety and tolerability of single and multiple intravenous doses of RSV604 as measured by vital signs, electrocardiographs (ECGs), adverse events, clinical laboratory evaluations.
  • Tolerability of single and multiple intravenous doses of RSV604, RSV604 as measured by vital signs, ECGs, adverse events, clinical laboratory evaluations

Secondary Outcome Measures:
  • Pharmacokinetics of single-dose RSV604 intravenous formulation administered orally and intravenously

Estimated Enrollment: 48
Study Start Date: October 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects, 18-50 years of age, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  • Vital signs within the following parameters:

oral body temperature between 35.0-37.5 °C systolic blood pressure, 85-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 100 beats per minute (bpm)

  • Female subjects must have been surgically sterilized at least 6 months prior to screening, with supportive clinical documentation OR Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
  • 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.

Exclusion Criteria:

  • Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use or has a urine cotinine greater than 300 ng/ml
  • Participation in any clinical investigation involving medical intervention within 4 weeks before study start
  • Donation or loss of 400 ml or more of blood within 8 weeks prior to before study start
  • Significant illness within 2 weeks before study start
  • A past personal or close family medical history of clinically significant ECG abnormalities or of a prolonged QT-interval syndrome.
  • History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
  • History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
  • History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug particularly benzodiazepines.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416442


Locations
United Kingdom
Novartis Investigative Site
Horsham, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Investigator site
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00416442     History of Changes
Other Study ID Numbers: CRSV604A2101
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
healthy subjects, safety, tolerability, dose escalation, pharmacokinetics, benzodiazepine
Healthy male and female subjects