We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885989
First Posted: April 22, 2009
Last Update Posted: January 29, 2010
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:
Solvay Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe. [ Time Frame: 48 hours ]
  • 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 ]

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

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 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • not healthy
  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): 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

Responsible Party: Ellis Ides, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00885989     History of Changes
Other Study ID Numbers: S338.1.002
2008-006753-40
First Submitted: January 30, 2009
First Posted: April 22, 2009
Last Update Posted: January 29, 2010
Last Verified: January 2010

Keywords provided by Solvay Pharmaceuticals:
SLV338
phase I
healthy volunteers