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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00416442
First received: December 27, 2006
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416442

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00416442     History of Changes
Other Study ID Numbers: CRSV604A2101
Study First Received: December 27, 2006
Last Updated: November 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 23, 2013