Safety of Single Intravenous Administration of S95010 in... | NCT03494712

Studies
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

NCT03494712

Sponsor

Institut de Recherches Internationales Servier

Status

Completed

Last Update Posted

Feb 17, 2020Actual

Enrollment

49Actual

Phase

Phase 1

Conditions

Cardiovascular Diseases

Interventions

S 95010
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-004180-12	EudraCT Number

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2018Actual

Primary Completion Date

Apr 10, 2019Actual

Completion Date

Apr 10, 2019Actual

First Submitted Date

Feb 16, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Name	Class
ADIR, a Servier Group company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S 95010	Experimental	Increasing single doses of S 95010 to 5 subjects.	Drug: S 95010
Placebo	Placebo Comparator	Increasing single doses of Placebo to 2 subjects.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S 95010	Drug	Single administration of S 95010 in healthy volunteers	S 95010

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by incidence of Adverse Events	Safety criterion	Through study completion, an average of 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SGS Clinical Pharmacology Unit - Stuivenberg Hospital		Antwerp		B-2060	Belgium

ID	Type	URL	Comment
	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Yes

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:

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.

Types

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/

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided