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Completed

NCT Number: NCT03494712

Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Clinical Pharmacology Unit - Stuivenberg Hospital

Antwerp, B-2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S 95010

Drug

Single administration of S 95010 in healthy volunteers

Placebo

Other

Single administration of placebo in healthy volunteers

Primary outcomes

  1. Safety assessed by incidence of Adverse Events

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

    Safety criterion

Secondary outcomes

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

    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)

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

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

    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)

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

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

    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)

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

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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