Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00885989
First received: January 30, 2009
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: SLV338
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Combined Single and Multiple Rising Dose Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV338 After Intravenous Administration in Healthy Male Subjects

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SLV338
5 - 1000 mg IV
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • not healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885989

Locations
United Kingdom
Site 1
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ellis Ides, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00885989     History of Changes
Other Study ID Numbers: S338.1.002, 2008-006753-40
Study First Received: January 30, 2009
Last Updated: January 28, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Solvay Pharmaceuticals:
SLV338
phase I
healthy volunteers

ClinicalTrials.gov processed this record on April 15, 2014