Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

Cardiovascular Diseases Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494712
• Other study ID #: CL1-95010-001
• Secondary ID: 2017-004180-12
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: February 2020
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 ?GT > ULN at selection

• History of renal dysfunction or GFR < 75mL/min/1.73 m2 (MDRD equation) at selection

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• S 95010
Single administration of S 95010 in healthy volunteers

Other:
• Placebo
Single administration of placebo in healthy volunteers

Locations

Country	Name	City	State
Belgium	SGS Clinical Pharmacology Unit - Stuivenberg Hospital	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by incidence of Adverse Events	Safety criterion	Through study completion, an average of 12 weeks
Secondary	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	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)
Secondary	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	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)
Secondary	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	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)

External Links

•   Results Summary