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

NCT00416442 | Completed Phase 1

• 1 other identifier: CRSV604A2101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

healthy subjects, safety, tolerability, dose escalation, pharmacokinetics, benzodiazepine; Healthy male and female subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetics of single-dose RSV604 intravenous formulation administered orally and intravenously

Interventions

RSV604 DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Horsham, United Kingdom

Location

MeSH Terms

Interventions

1-(2-fluorophenyl)-3-(2-oxo-5-phenyl-2,3-dihydro-1H-benzo(e)(1,4)diazepin-3-yl)urea

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2006
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

GB (1)