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

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ClinicalTrials.gov Identifier: NCT00885989
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: SLV338 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : May 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: SLV338
5 - 1000 mg IV
Placebo Comparator: 2 Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe. [ Time Frame: 48 hours ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 22, 2009    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010

Keywords provided by Solvay Pharmaceuticals:
SLV338
phase I
healthy volunteers