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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SLV338; Drug: Placebo

• Registration Number: NCT00885989
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2009-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-28
• Last Update Posted: 2010-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• healthy

Exclusion Criteria

• not healthy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SLV338	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG	7 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe.	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.	48 hours

Trial Locations

Locations (1)

Site 1; 🇬🇧 London, United Kingdom