Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Institut de Recherches Internationales Servier49 enrolled

Overview

The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

S 95010DRUG

Single administration of S 95010 in healthy volunteers

PlaceboOTHER

Single administration of placebo in healthy volunteers

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Young healthy male subjects aged between 18 and 45 years (both inclusive) Exclusion Criteria: * Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations * Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator * History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT \> ULN at selection * History of renal dysfunction or GFR \< 75mL/min/1.73 m2 (MDRD equation) at selection

Locations (1)

SGS Clinical Pharmacology Unit - Stuivenberg Hospital

Antwerp, Belgium

Outcomes

Primary Outcomes

Safety assessed by incidence of Adverse Events

Safety criterion

Time frame: Through study completion, an average of 12 weeks

Secondary Outcomes

The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)

Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples

Time frame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)

The PK profile of S 95010 plasma concentration : Plasma half-life

Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples

Time frame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)

The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)

Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples

Time frame: During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)

Data from ClinicalTrials.gov

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