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

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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • not healthy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00885989

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

Responsible Party: Ellis Ides, Solvay Pharmaceuticals Identifier: NCT00885989     History of Changes
Other Study ID Numbers: S338.1.002
Study First Received: January 30, 2009
Last Updated: January 28, 2010

Keywords provided by Solvay Pharmaceuticals:
phase I
healthy volunteers processed this record on September 19, 2017