Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Other: Placebo; Drug: S 95010

• Registration Number: NCT03494712
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-16
• Study Start: 2018-02-21
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Primary Completion: 2019-04-10
• Study Completion: 2019-04-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Increasing single doses of Placebo to 2 subjects.
S 95010	S 95010	Increasing single doses of S 95010 to 5 subjects.

Primary Outcome Measures

Name	Time	Method
Safety assessed by incidence of Adverse Events	Through study completion, an average of 12 weeks	Safety criterion

Secondary Outcome Measures

Name	Time	Method
The PK profile of S 95010 plasma concentration : Plasma half-life	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples
The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples
The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)	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)	Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples

Trial Locations

Locations (1)

SGS Clinical Pharmacology Unit - Stuivenberg Hospital; 🇧🇪 Antwerpen, Belgium