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Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03494712
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
ADIR Association
Information provided by (Responsible Party):
Servier ( 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: S 95010 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : April 14, 2019
Estimated Study Completion Date : April 14, 2019

Arm Intervention/treatment
Experimental: S 95010
Increasing single doses of S 95010 to 5 subjects.
Drug: S 95010
Single administration of S 95010 in healthy volunteers

Placebo Comparator: Placebo
Increasing single doses of Placebo to 2 subjects.
Other: Placebo
Single administration of placebo in healthy volunteers




Primary Outcome Measures :
  1. Safety assessed by incidence of Adverse Events [ Time Frame: Through study completion, an average of 12 weeks ]
    Safety criterion


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494712


Contacts
Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinicaltrials@servier.com

Locations
Belgium
SGS Clinical Pharmacology Unit Recruiting
Antwerpen, Belgium, B-2060
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR Association

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT03494712     History of Changes
Other Study ID Numbers: CL1-95010-001
2017-004180-12 ( EudraCT Number )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies in patients:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: https://clinicaltrials.servier.com/

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
healthy volunteer
antimiR
single ascending dose

Additional relevant MeSH terms:
Cardiovascular Diseases