Cardiovascular DiseasesPhase 1NCT03494712
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
A Phase 1 study testing S 95010 in people with Cardiovascular Diseases, run by Institut de Recherches Internationales Servier at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- S 95010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Feb 2018to 10 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy male subjects aged between 18 and 45 years (both inclusive)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Clinical Pharmacology Unit - Stuivenberg Hospital
Antwerp, B-2060
About this study
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.
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- S 95010, Placebo
- Keywords
- healthy volunteer, antimiR, single ascending dose
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S 95010Drug
Single administration of S 95010 in healthy volunteers
PlaceboOther
Single administration of placebo in healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| S 95010 | Experimental | Increasing single doses of S 95010 to 5 subjects. Receives: Drug: S 95010 |
| Placebo | Placebo comparator | Increasing single doses of Placebo to 2 subjects. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of Adverse Events
Safety criterion
Measured: Through study completion, an average of 12 weeks
Secondary outcomes (3)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start21 Feb 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494712
- Sponsor's protocol ID
- CL1-95010-001
- Other IDs
- 2017-004180-12, 2017
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03494712
- Acronym / sponsor ID
- CL1-95010-001
- Conditions
- Cardiovascular Diseases
- Keywords
- healthy volunteer, antimiR, single ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S 95010 | Experimental | Drug: S 95010Increasing single doses of S 95010 to 5 subjects. |
| Placebo | Placebo comparator | Other: PlaceboIncreasing single doses of Placebo to 2 subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young healthy male subjects aged between 18 and 45 years (both inclusive)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S 95010Single administration of S 95010 in healthy volunteers | Drug | S 95010 |
| PlaceboSingle administration of placebo in healthy volunteers | Other | Placebo |
Primary outcome
Safety assessed by incidence of Adverse Events
Time frame: Through study completion, an average of 12 weeks
Safety criterion
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S 95010 in people with Cardiovascular Diseases, run by Institut de Recherches Internationales Servier at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by incidence of Adverse Events (time frame: Through study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.