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

Phase 1CompletedNCT00885989

Solvay Pharmaceuticals42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

SLV338DRUG

5 - 1000 mg IV

PlaceboDRUG

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy Exclusion Criteria: * not healthy

Locations (1)

Site 1

London, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG

Time frame: 7 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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