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

NCT ID: NCT00416442

Last Updated: 2011-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

Brief Summary

This study is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

RSV604

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative Site

Horsham, , United Kingdom

Countries

United Kingdom

Other Identifiers

CRSV604A2101

Identifier Type: -

Identifier Source: org_study_id